STAPLE, IMPLANTABLE
This device is manufactured by COVIDIEN, COVIDIEN FORMERLY US SURGICAL A DIVISION OF TYCO HEALTHCARE, COVIDIEN FORMERLY USSC PUERTO RICO, US SURGICAL PUERTO RICO.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Tissue Breakdown | 6 | Patient |
| 2024 | Insufficient Information | 3 | Patient |
| 2024 | Failure to Anastomose | 1 | Patient |
| 2024 | Misfire | 1 | Device |
| 2024 | Mechanics Altered | 2 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Failure to Form Staple | 7 | Device |
| 2024 | Failure to Fire | 6 | Device |
| 2024 | Difficult to Open or Close | 1 | Device |
| 2024 | Detachment of Device or Device Component | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Unspecified Tissue Injury | 2 | Patient |
| 2023 | Tissue Breakdown | 5 | Patient |
| 2023 | Laceration(s) | 1 | Patient |
| 2023 | Insufficient Information | 4 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2023 | Failure to Anastomose | 5 | Patient |
| 2023 | Appropriate Term / Code Not Available | 2 | Patient |
| 2023 | No Device Output | 1 | Device |
| 2023 | Misfire | 2 | Device |
| 2023 | Mechanics Altered | 2 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Failure to Form Staple | 9 | Device |
| 2023 | Failure to Fire | 16 | Device |
| 2023 | Expulsion | 2 | Device |
| 2023 | Entrapment of Device | 3 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Hematoma | 1 | Patient |
| 2022 | Failure to Anastomose | 1 | Patient |
| 2022 | Positioning Failure | 1 | Device |
| 2022 | Misfire | 1 | Device |
| 2022 | Mechanics Altered | 2 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Failure to Form Staple | 10 | Device |
| 2022 | Failure to Fire | 19 | Device |
| 2022 | Failure to Cut | 2 | Device |
| 2022 | Entrapment of Device | 3 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2021 | Unspecified Tissue Injury | 1 | Patient |
| 2021 | Shock | 1 | Patient |
| 2021 | Pain | 1 | Patient |
| 2021 | Emotional Changes | 1 | Patient |
| 2021 | Ascites | 1 | Patient |
| 2021 | Appropriate Term / Code Not Available | 1 | Patient |
| 2021 | Misfire | 1 | Device |
| 2021 | Mechanics Altered | 1 | Device |
| 2021 | Detachment of Device or Device Component | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Insufficient Information | 1 | Patient |
| 2020 | Misfire | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Use of Device Problem | 1 | Device |
| 2019 | Physical Resistance/Sticking | 2 | Device |
| 2019 | Noise, Audible | 1 | Device |
| 2019 | Misfire | 8 | Device |
| 2019 | Mechanics Altered | 22 | Device |
| 2019 | Mechanical Jam | 1 | Device |
| 2019 | Loss of or Failure to Bond | 4 | Device |
| 2019 | Human-Device Interface Problem | 1 | Device |
| 2019 | Gas/Air Leak | 2 | Device |
| 2019 | Fluid/Blood Leak | 4 | Device |
| 2019 | Failure to Form Staple | 35 | Device |
| 2019 | Failure to Fire | 64 | Device |
| 2019 | Failure to Align | 3 | Device |
| 2019 | Entrapment of Device | 2 | Device |
| 2019 | Difficult to Open or Close | 9 | Device |
| 2019 | Detachment of Device or Device Component | 4 | Device |
| 2019 | Break | 2 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2018 | Physical Resistance/Sticking | 1 | Device |
| 2018 | Physical Resistance | 1 | Device |
| 2018 | Misfire | 15 | Device |
| 2018 | Mechanics Altered | 36 | Device |
| 2018 | Loss of or Failure to Bond | 2 | Device |
| 2018 | Human-Device Interface Problem | 1 | Device |
| 2018 | Gas/Air Leak | 4 | Device |
| 2018 | Fluid/Blood Leak | 3 | Device |
| 2018 | Firing Problem | 4 | Device |
| 2018 | Failure to Form Staple | 36 | Device |
| 2018 | Failure to Fire | 75 | Device |
| 2018 | Failure to Cut | 1 | Device |
| 2018 | Expulsion | 1 | Device |
| 2018 | Difficult to Remove | 1 | Device |
| 2018 | Difficult to Open or Close | 3 | Device |
| 2018 | Difficult or Delayed Positioning | 4 | Device |
| 2018 | Device Inoperable | 1 | Device |
| 2018 | Detachment of Device or Device Component | 6 | Device |
| 2018 | Detachment Of Device Component | 2 | Device |
| 2018 | Component or Accessory Incompatibility | 1 | Device |
| 2018 | Break | 2 | Device |
| 2018 | Air Leak | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2017 | Retraction Problem | 3 | Device |
| 2017 | Positioning Problem | 1 | Device |
| 2017 | Physical Resistance | 1 | Device |
| 2017 | Misfire | 26 | Device |
| 2017 | Mechanics Altered | 41 | Device |
| 2017 | Mechanical Jam | 2 | Device |
| 2017 | Loss of or Failure to Bond | 1 | Device |
| 2017 | Human-Device Interface Problem | 3 | Device |
| 2017 | Fluid/Blood Leak | 2 | Device |
| 2017 | Firing Problem | 1 | Device |
| 2017 | Failure to Form Staple | 51 | Device |
| 2017 | Failure to Fire | 54 | Device |
| 2017 | Failure to Cut | 1 | Device |
| 2017 | Failure to Align | 2 | Device |
| 2017 | Failure To Adhere Or Bond | 1 | Device |
| 2017 | Entrapment of Device | 7 | Device |
| 2017 | Difficult to Remove | 2 | Device |
| 2017 | Difficult to Open or Close | 12 | Device |
| 2017 | Detachment Of Device Component | 10 | Device |
| 2017 | Break | 5 | Device |
| 2017 | Appropriate Term/Code Not Available | 1 | Device |
| 2017 | Air Leak | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2016 | Positioning Failure | 3 | Device |
| 2016 | Physical Resistance | 1 | Device |
| 2016 | Misfire | 2 | Device |
| 2016 | Mechanics Altered | 2 | Device |
| 2016 | Fluid/Blood Leak | 2 | Device |
| 2016 | Failure to Form Staple | 11 | Device |
| 2016 | Failure to Fire | 7 | Device |
| 2016 | Failure to Cycle | 1 | Device |
| 2016 | Failure To Adhere Or Bond | 1 | Device |
| 2016 | Entrapment of Device | 1 | Device |
| 2016 | Component Missing | 2 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2015 | Positioning Failure | 1 | Device |
| 2015 | Mechanics Altered | 1 | Device |
| 2015 | Failure to Form Staple | 3 | Device |
| 2015 | Failure to Fire | 3 | Device |
| 2015 | Device Operates Differently Than Expected | 1 | Device |
| 2015 | Device Inoperable | 1 | Device |
| 2014 | Failure to Form Staple | 2 | Device |