STAPLE, IMPLANTABLE
This device is manufactured by COVIDIEN, COVIDIEN FORMERLY USSC PUERTO RICO, US SURGICAL PUERTO RICO.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Ventricular Fibrillation | 1 | Patient |
| 2024 | Unspecified Tissue Injury | 3 | Patient |
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Unintended Radiation Exposure | 2 | Patient |
| 2024 | Tissue Breakdown | 33 | Patient |
| 2024 | Stroke/CVA | 1 | Patient |
| 2024 | Stenosis | 1 | Patient |
| 2024 | Sepsis | 1 | Patient |
| 2024 | Myocardial Infarction | 1 | Patient |
| 2024 | Laceration(s) | 6 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Failure to Anastomose | 47 | Patient |
| 2024 | Product Quality Problem | 1 | Device |
| 2024 | Noise, Audible | 1 | Device |
| 2024 | No Device Output | 1 | Device |
| 2024 | Misfire | 2 | Device |
| 2024 | Mechanics Altered | 8 | Device |
| 2024 | Material Twisted/Bent | 1 | Device |
| 2024 | Material Separation | 1 | Device |
| 2024 | Loss of or Failure to Bond | 6 | Device |
| 2024 | Human-Device Interface Problem | 2 | Device |
| 2024 | Failure to Form Staple | 20 | Device |
| 2024 | Failure to Fire | 7 | Device |
| 2024 | Failure to Cut | 2 | Device |
| 2024 | Failure to Align | 4 | Device |
| 2024 | Expulsion | 2 | Device |
| 2024 | Entrapment of Device | 1 | Device |
| 2024 | Difficult to Remove | 10 | Device |
| 2024 | Difficult to Insert | 1 | Device |
| 2024 | Device Slipped | 2 | Device |
| 2024 | Detachment of Device or Device Component | 11 | Device |
| 2024 | Break | 6 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Unspecified Tissue Injury | 27 | Patient |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Unintended Radiation Exposure | 2 | Patient |
| 2023 | Tissue Breakdown | 17 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Stenosis | 4 | Patient |
| 2023 | Skin Inflammation/ Irritation | 1 | Patient |
| 2023 | Sepsis | 1 | Patient |
| 2023 | Scar Tissue | 1 | Patient |
| 2023 | Peritonitis | 2 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Obstruction/Occlusion | 2 | Patient |
| 2023 | Nausea | 1 | Patient |
| 2023 | Muscle Weakness/Atrophy | 1 | Patient |
| 2023 | Laceration(s) | 5 | Patient |
| 2023 | Ischemia | 1 | Patient |
| 2023 | Insufficient Information | 9 | Patient |
| 2023 | Inflammation | 1 | Patient |
| 2023 | Hernia | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 11 | Patient |
| 2023 | Fungal Infection | 1 | Patient |
| 2023 | Fistula | 1 | Patient |
| 2023 | Fibrosis | 1 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Failure to Anastomose | 57 | Patient |
| 2023 | Emotional Changes | 1 | Patient |
| 2023 | Distress | 1 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Depression | 1 | Patient |
| 2023 | Deformity/ Disfigurement | 1 | Patient |
| 2023 | Decreased Appetite | 1 | Patient |
| 2023 | Bowel Perforation | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 3 | Patient |
| 2023 | Anemia | 1 | Patient |
| 2023 | Ambulation Difficulties | 1 | Patient |
| 2023 | Adhesion(s) | 1 | Patient |
| 2023 | Abscess | 2 | Patient |
| 2023 | Abrasion | 1 | Patient |
| 2023 | Abdominal Pain | 1 | Patient |
| 2023 | Abdominal Distention | 1 | Patient |
| 2023 | Product Quality Problem | 1 | Device |
| 2023 | Positioning Problem | 4 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | No Device Output | 2 | Device |
| 2023 | Misfire | 7 | Device |
| 2023 | Misassembly by Users | 1 | Device |
| 2023 | Mechanics Altered | 7 | Device |
| 2023 | Mechanical Jam | 1 | Device |
| 2023 | Material Twisted/Bent | 7 | Device |
| 2023 | Loss of or Failure to Bond | 17 | Device |
| 2023 | Human-Device Interface Problem | 2 | Device |
| 2023 | Failure to Form Staple | 33 | Device |
| 2023 | Failure to Fire | 14 | Device |
| 2023 | Failure to Cut | 3 | Device |
| 2023 | Failure to Align | 8 | Device |
| 2023 | Entrapment of Device | 2 | Device |
| 2023 | Difficult to Remove | 18 | Device |
| 2023 | Device Slipped | 7 | Device |
| 2023 | Device Damaged Prior to Use | 1 | Device |
| 2023 | Detachment of Device or Device Component | 16 | Device |
| 2023 | Break | 6 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 35 | Device |
| 2022 | Urinary Tract Infection | 2 | Patient |
| 2022 | Urinary Retention | 2 | Patient |
| 2022 | Unspecified Tissue Injury | 7 | Patient |
| 2022 | Unintended Radiation Exposure | 3 | Patient |
| 2022 | Stenosis | 2 | Patient |
| 2022 | Scar Tissue | 2 | Patient |
| 2022 | Pain | 2 | Patient |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Inflammation | 2 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 5 | Patient |
| 2022 | Foreign Body Reaction | 2 | Patient |
| 2022 | Fluid Discharge | 2 | Patient |
| 2022 | Failure to Anastomose | 7 | Patient |
| 2022 | Erythema | 2 | Patient |
| 2022 | Emotional Changes | 2 | Patient |
| 2022 | Electrolyte Imbalance | 2 | Patient |
| 2022 | Distress | 2 | Patient |
| 2022 | Ascites | 2 | Patient |
| 2022 | Appropriate Term / Code Not Available | 2 | Patient |
| 2022 | Product Quality Problem | 1 | Device |
| 2022 | Positioning Problem | 3 | Device |
| 2022 | Patient Device Interaction Problem | 1 | Device |
| 2022 | Packaging Problem | 1 | Device |
| 2022 | Noise, Audible | 1 | Device |
| 2022 | No Device Output | 1 | Device |
| 2022 | Misfire | 7 | Device |
| 2022 | Mechanics Altered | 6 | Device |
| 2022 | Material Twisted/Bent | 1 | Device |
| 2022 | Material Protrusion/Extrusion | 2 | Device |
| 2022 | Loss of or Failure to Bond | 4 | Device |
| 2022 | Failure to Form Staple | 32 | Device |
| 2022 | Failure to Fire | 17 | Device |
| 2022 | Failure to Cut | 2 | Device |
| 2022 | Difficult to Remove | 13 | Device |
| 2022 | Difficult to Insert | 1 | Device |
| 2022 | Device Slipped | 5 | Device |
| 2022 | Detachment of Device or Device Component | 19 | Device |
| 2022 | Break | 4 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 32 | Device |
| 2021 | Valvular Insufficiency/ Regurgitation | 1 | Patient |
| 2021 | Urinary Tract Infection | 1 | Patient |
| 2021 | Unspecified Tissue Injury | 1 | Patient |
| 2021 | Ulcer | 1 | Patient |
| 2021 | Thrombosis/Thrombus | 1 | Patient |
| 2021 | Tachycardia | 1 | Patient |
| 2021 | Swelling/ Edema | 1 | Patient |
| 2021 | Septic Shock | 1 | Patient |
| 2021 | Sepsis | 1 | Patient |
| 2021 | Respiratory Failure | 1 | Patient |
| 2021 | Respiratory Alkalosis | 1 | Patient |
| 2021 | Renal Failure | 1 | Patient |
| 2021 | Quadriplegia | 1 | Patient |
| 2021 | Purulent Discharge | 1 | Patient |
| 2021 | Pleural Effusion | 1 | Patient |
| 2021 | Peritonitis | 1 | Patient |
| 2021 | Pain | 1 | Patient |
| 2021 | Obstruction/Occlusion | 1 | Patient |
| 2021 | Necrosis | 1 | Patient |
| 2021 | Nausea | 1 | Patient |
| 2021 | Muscle Weakness/Atrophy | 1 | Patient |
| 2021 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2021 | Loss of consciousness | 1 | Patient |
| 2021 | Lethargy | 1 | Patient |
| 2021 | Ischemia | 1 | Patient |
| 2021 | Inflammation | 1 | Patient |
| 2021 | Hypoxia | 1 | Patient |
| 2021 | Hyponatremia | 1 | Patient |
| 2021 | Hypernatremia | 1 | Patient |
| 2021 | Hernia | 1 | Patient |
| 2021 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2021 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2021 | Fungal Infection | 1 | Patient |
| 2021 | Foreign Body Reaction | 1 | Patient |
| 2021 | Fluid Discharge | 2 | Patient |
| 2021 | Fistula | 1 | Patient |
| 2021 | Fibrosis | 1 | Patient |
| 2021 | Fatigue | 1 | Patient |
| 2021 | Failure to Anastomose | 2 | Patient |
| 2021 | Electrolyte Imbalance | 1 | Patient |
| 2021 | Discomfort | 1 | Patient |
| 2021 | Diarrhea | 1 | Patient |
| 2021 | Dehydration | 1 | Patient |
| 2021 | Decreased Appetite | 1 | Patient |
| 2021 | Confusion/ Disorientation | 1 | Patient |
| 2021 | Bacterial Infection | 1 | Patient |
| 2021 | Ascites | 1 | Patient |
| 2021 | Appropriate Term / Code Not Available | 1 | Patient |
| 2021 | Anemia | 1 | Patient |
| 2021 | Ambulation Difficulties | 1 | Patient |
| 2021 | Adhesion(s) | 1 | Patient |
| 2021 | Abscess | 1 | Patient |
| 2021 | Abdominal Pain | 1 | Patient |
| 2021 | Misfire | 1 | Device |
| 2021 | Mechanics Altered | 1 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 2 | Device |