DISPOSABLE STAPLER
This device is manufactured by COVIDIEN LP NORTH HAVEN, DAVIS & GECK CARIBE, US SURGICAL PUERTO RICO.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Unintended Radiation Exposure | 1 | Patient |
| 2024 | Tissue Breakdown | 5 | Patient |
| 2024 | Stroke/CVA | 1 | Patient |
| 2024 | Stenosis | 1 | Patient |
| 2024 | Sepsis | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Myocardial Infarction | 1 | Patient |
| 2024 | Insufficient Information | 10 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 6 | Patient |
| 2024 | Failure to Anastomose | 2 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Unintended System Motion | 1 | Device |
| 2024 | Unintended Movement | 1 | Device |
| 2024 | Premature End-of-Life Indicator | 1 | Device |
| 2024 | Misfire | 6 | Device |
| 2024 | Mechanical Jam | 1 | Device |
| 2024 | Insufficient Information | 4 | Device |
| 2024 | Human-Device Interface Problem | 3 | Device |
| 2024 | Failure to Form Staple | 2 | Device |
| 2024 | Failure to Fire | 25 | Device |
| 2024 | Failure to Cut | 1 | Device |
| 2024 | Entrapment of Device | 5 | Device |
| 2024 | Difficult to Remove | 1 | Device |
| 2024 | Difficult to Open or Close | 4 | Device |
| 2024 | Device Displays Incorrect Message | 2 | Device |
| 2024 | Detachment of Device or Device Component | 1 | Device |
| 2024 | Component or Accessory Incompatibility | 2 | Device |
| 2024 | Calibration Problem | 1 | Device |
| 2024 | Break | 4 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Unspecified Tissue Injury | 5 | Patient |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Unintended Radiation Exposure | 1 | Patient |
| 2023 | Tissue Breakdown | 12 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Stenosis | 1 | Patient |
| 2023 | Sepsis | 1 | Patient |
| 2023 | Organ Dehiscence | 1 | Patient |
| 2023 | Obstruction/Occlusion | 2 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2023 | Laceration(s) | 3 | Patient |
| 2023 | Insufficient Information | 18 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 7 | Patient |
| 2023 | Hematoma | 2 | Patient |
| 2023 | Fistula | 3 | Patient |
| 2023 | Fever | 1 | Patient |
| 2023 | Failure to Anastomose | 5 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Coma | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Anemia | 1 | Patient |
| 2023 | Abscess | 1 | Patient |
| 2023 | Abdominal Pain | 2 | Patient |
| 2023 | Retraction Problem | 2 | Device |
| 2023 | Physical Resistance/Sticking | 2 | Device |
| 2023 | Misfire | 11 | Device |
| 2023 | Mechanics Altered | 2 | Device |
| 2023 | Mechanical Jam | 1 | Device |
| 2023 | Insufficient Information | 15 | Device |
| 2023 | Human-Device Interface Problem | 3 | Device |
| 2023 | Firing Problem | 1 | Device |
| 2023 | Failure to Form Staple | 6 | Device |
| 2023 | Failure to Fire | 37 | Device |
| 2023 | Fail-Safe Problem | 1 | Device |
| 2023 | Entrapment of Device | 10 | Device |
| 2023 | Difficult to Open or Close | 4 | Device |
| 2023 | Device Displays Incorrect Message | 4 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Component or Accessory Incompatibility | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 17 | Device |
| 2022 | Unspecified Tissue Injury | 4 | Patient |
| 2022 | Sepsis | 1 | Patient |
| 2022 | Necrosis | 1 | Patient |
| 2022 | Insufficient Information | 3 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Hematoma | 1 | Patient |
| 2022 | Failure to Anastomose | 2 | Patient |
| 2022 | Appropriate Term / Code Not Available | 1 | Patient |
| 2022 | Unintended Movement | 1 | Device |
| 2022 | Misfire | 8 | Device |
| 2022 | Mechanical Jam | 1 | Device |
| 2022 | Insufficient Information | 28 | Device |
| 2022 | Human-Device Interface Problem | 7 | Device |
| 2022 | Failure to Form Staple | 11 | Device |
| 2022 | Failure to Fire | 51 | Device |
| 2022 | Failure to Cut | 1 | Device |
| 2022 | Expulsion | 1 | Device |
| 2022 | Entrapment of Device | 4 | Device |
| 2022 | Difficult to Open or Close | 2 | Device |
| 2022 | Difficult or Delayed Positioning | 1 | Device |
| 2022 | Device Displays Incorrect Message | 1 | Device |
| 2022 | Detachment of Device or Device Component | 3 | Device |
| 2022 | Component or Accessory Incompatibility | 1 | Device |
| 2022 | Break | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2021 | Unspecified Tissue Injury | 2 | Patient |
| 2021 | Stenosis | 1 | Patient |
| 2021 | Peritonitis | 1 | Patient |
| 2021 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Failure to Fire | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2020 | Entrapment of Device | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2019 | Unintended Movement | 3 | Device |
| 2019 | Separation Failure | 1 | Device |
| 2019 | Physical Resistance/Sticking | 1 | Device |
| 2019 | Noise, Audible | 1 | Device |
| 2019 | Misfire | 15 | Device |
| 2019 | Mechanics Altered | 1 | Device |
| 2019 | Loss of or Failure to Bond | 2 | Device |
| 2019 | Human-Device Interface Problem | 5 | Device |
| 2019 | Gas/Air Leak | 1 | Device |
| 2019 | Fluid/Blood Leak | 2 | Device |
| 2019 | Failure to Read Input Signal | 1 | Device |
| 2019 | Failure to Form Staple | 13 | Device |
| 2019 | Failure to Fire | 98 | Device |
| 2019 | Failure to Cut | 1 | Device |
| 2019 | Entrapment of Device | 11 | Device |
| 2019 | Difficult to Remove | 1 | Device |
| 2019 | Difficult to Open or Close | 19 | Device |
| 2019 | Difficult or Delayed Positioning | 2 | Device |
| 2019 | Detachment of Device or Device Component | 6 | Device |
| 2019 | Component or Accessory Incompatibility | 2 | Device |
| 2019 | Break | 6 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2018 | Unintended Movement | 2 | Device |
| 2018 | Positioning Problem | 1 | Device |
| 2018 | Physical Resistance/Sticking | 1 | Device |
| 2018 | Noise, Audible | 3 | Device |
| 2018 | Misfire | 26 | Device |
| 2018 | Mechanics Altered | 1 | Device |
| 2018 | Mechanical Problem | 4 | Device |
| 2018 | Mechanical Jam | 1 | Device |
| 2018 | Material Too Rigid or Stiff | 1 | Device |
| 2018 | Malposition of Device | 1 | Device |
| 2018 | Human-Device Interface Problem | 8 | Device |
| 2018 | Gas/Air Leak | 1 | Device |
| 2018 | Firing Problem | 11 | Device |
| 2018 | Failure to Read Input Signal | 1 | Device |
| 2018 | Failure to Form Staple | 13 | Device |
| 2018 | Failure to Fire | 151 | Device |
| 2018 | Entrapment of Device | 1 | Device |
| 2018 | Difficult to Remove | 2 | Device |
| 2018 | Difficult to Open or Close | 16 | Device |
| 2018 | Detachment of Device or Device Component | 2 | Device |
| 2018 | Detachment Of Device Component | 1 | Device |
| 2018 | Component or Accessory Incompatibility | 3 | Device |
| 2018 | Calibration Problem | 1 | Device |
| 2018 | Break | 2 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 18 | Device |
| 2017 | Tissue Breakdown | 2 | Patient |
| 2017 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2017 | Unintended Movement | 1 | Device |
| 2017 | Noise, Audible | 1 | Device |
| 2017 | Misfire | 4 | Device |
| 2017 | Mechanics Altered | 1 | Device |
| 2017 | Mechanical Jam | 1 | Device |
| 2017 | Human-Device Interface Problem | 1 | Device |
| 2017 | Fluid/Blood Leak | 2 | Device |
| 2017 | Failure to Form Staple | 2 | Device |
| 2017 | Failure to Fire | 12 | Device |
| 2017 | Entrapment of Device | 3 | Device |
| 2017 | Difficult to Open or Close | 2 | Device |
| 2017 | Detachment Of Device Component | 1 | Device |
| 2017 | Break | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2016 | Self-Activation or Keying | 1 | Device |
| 2016 | Noise, Audible | 1 | Device |
| 2016 | Misfire | 1 | Device |
| 2016 | Break | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Ambulation Difficulties | 1 | Patient |
| 2015 | Misfire | 1 | Device |
| 2015 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 1988 | Physical Resistance/Sticking | 1 | Device |
| 1988 | Mechanical Jam | 1 | Device |