STAPLE, IMPLANTABLE
This device is manufactured by ETHICON, ETHICON ENDO-SURGERY, ETHICON ENDO-SURGERY JOHNSON AND JOHNSON COMPANY, ETHICON ENDO-SURGICAL.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Tissue Injury | 1 | Patient |
| 2024 | Structural Problem | 1 | Device |
| 2024 | No Apparent Adverse Event | 3 | Device |
| 2024 | Mechanical Problem | 2 | Device |
| 2024 | Mechanical Jam | 3 | Device |
| 2024 | Failure to Form Staple | 3 | Device |
| 2024 | Failure to Fire | 8 | Device |
| 2024 | Ejection Problem | 1 | Device |
| 2024 | Difficult to Open or Close | 5 | Device |
| 2024 | Delivered as Unsterile Product | 1 | Device |
| 2023 | Pneumothorax | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 3 | Patient |
| 2023 | Failure to Anastomose | 1 | Patient |
| 2023 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2023 | No Apparent Adverse Event | 2 | Device |
| 2023 | Mechanical Problem | 5 | Device |
| 2023 | Mechanical Jam | 1 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Failure to Form Staple | 9 | Device |
| 2023 | Failure to Fire | 28 | Device |
| 2023 | Failure to Cut | 2 | Device |
| 2023 | Ejection Problem | 1 | Device |
| 2023 | Difficult to Open or Close | 18 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2022 | Unintended Ejection | 1 | Device |
| 2022 | Positioning Failure | 1 | Device |
| 2022 | No Apparent Adverse Event | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Material Integrity Problem | 3 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Firing Problem | 1 | Device |
| 2022 | Failure to Form Staple | 4 | Device |
| 2022 | Failure to Fire | 16 | Device |
| 2022 | Difficult to Open or Close | 13 | Device |
| 2022 | Component or Accessory Incompatibility | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2019 | Unexpected Therapeutic Results | 1 | Device |
| 2019 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2019 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2019 | Retraction Problem | 7 | Device |
| 2019 | Physical Resistance/Sticking | 2 | Device |
| 2019 | Misfire | 1 | Device |
| 2019 | Mechanical Problem | 6 | Device |
| 2019 | Mechanical Jam | 15 | Device |
| 2019 | Material Protrusion/Extrusion | 1 | Device |
| 2019 | Loose or Intermittent Connection | 3 | Device |
| 2019 | Firing Problem | 5 | Device |
| 2019 | Failure to Read Input Signal | 1 | Device |
| 2019 | Failure to Form Staple | 25 | Device |
| 2019 | Failure to Fire | 28 | Device |
| 2019 | Failure to Cut | 1 | Device |
| 2019 | Failure to Advance | 2 | Device |
| 2019 | Difficult to Open or Close | 24 | Device |
| 2019 | Difficult to Insert | 1 | Device |
| 2019 | Detachment of Device or Device Component | 1 | Device |
| 2019 | Defective Device | 3 | Device |
| 2019 | Defective Component | 1 | Device |
| 2019 | Component Missing | 1 | Device |
| 2019 | Complete Blockage | 2 | Device |
| 2019 | Break | 2 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2019 | Activation, Positioning or Separation Problem | 1 | Device |
| 2018 | Structural Problem | 1 | Device |
| 2018 | Sticking | 2 | Device |
| 2018 | Retraction Problem | 8 | Device |
| 2018 | Power Problem | 1 | Device |
| 2018 | Positioning Failure | 1 | Device |
| 2018 | Physical Resistance/Sticking | 7 | Device |
| 2018 | Partial Blockage | 1 | Device |
| 2018 | Output Problem | 1 | Device |
| 2018 | Noise, Audible | 1 | Device |
| 2018 | Misfire | 1 | Device |
| 2018 | Mechanical Problem | 5 | Device |
| 2018 | Mechanical Jam | 40 | Device |
| 2018 | Material Twisted/Bent | 1 | Device |
| 2018 | Material Puncture/Hole | 1 | Device |
| 2018 | Material Protrusion/Extrusion | 1 | Device |
| 2018 | Loose or Intermittent Connection | 4 | Device |
| 2018 | Leak/Splash | 1 | Device |
| 2018 | Insufficient Information | 6 | Device |
| 2018 | Firing Problem | 25 | Device |
| 2018 | Failure to Form Staple | 45 | Device |
| 2018 | Failure to Fire | 42 | Device |
| 2018 | Failure to Cut | 6 | Device |
| 2018 | Failure to Advance | 2 | Device |
| 2018 | Entrapment of Device | 1 | Device |
| 2018 | Difficult to Remove | 4 | Device |
| 2018 | Difficult to Open or Close | 78 | Device |
| 2018 | Difficult to Insert | 1 | Device |
| 2018 | Device Packaging Compromised | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 4 | Device |
| 2018 | Device Inoperable | 2 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2018 | Defective Device | 6 | Device |
| 2018 | Complete Blockage | 4 | Device |
| 2018 | Break | 6 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2018 | Activation, Positioning or Separation Problem | 3 | Device |
| 2017 | Sticking | 2 | Device |
| 2017 | Retraction Problem | 1 | Device |
| 2017 | Positioning Problem | 2 | Device |
| 2017 | Positioning Failure | 1 | Device |
| 2017 | Physical Resistance | 1 | Device |
| 2017 | Out-Of-Box Failure | 1 | Device |
| 2017 | Noise, Audible | 2 | Device |
| 2017 | No Display/Image | 1 | Device |
| 2017 | Misfire | 3 | Device |
| 2017 | Mechanical Problem | 4 | Device |
| 2017 | Mechanical Jam | 10 | Device |
| 2017 | Material Protrusion/Extrusion | 1 | Device |
| 2017 | Material Fragmentation | 2 | Device |
| 2017 | Material Deformation | 1 | Device |
| 2017 | Insufficient Information | 3 | Device |
| 2017 | Failure to Form Staple | 19 | Device |
| 2017 | Failure to Fire | 11 | Device |
| 2017 | Failure to Cut | 1 | Device |
| 2017 | Difficult to Remove | 1 | Device |
| 2017 | Difficult to Open or Close | 19 | Device |
| 2017 | Difficult to Insert | 1 | Device |
| 2017 | Device Packaging Compromised | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 6 | Device |
| 2017 | Device Inoperable | 2 | Device |
| 2017 | Detachment Of Device Component | 1 | Device |
| 2017 | Delivered as Unsterile Product | 1 | Device |
| 2017 | Defective Device | 1 | Device |
| 2017 | Break | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2017 | Activation, Positioning or Separation Problem | 1 | Device |
| 2016 | Failure to Fire | 4 | Device |
| 2016 | Failure to Advance | 1 | Device |
| 2016 | Difficult to Open or Close | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 1 | Device |
| 2014 | Misfire | 1 | Device |
| 2014 | Mechanical Jam | 3 | Device |
| 2014 | Failure to Form Staple | 2 | Device |
| 2014 | Failure to Cut | 1 | Device |
| 2014 | Entrapment of Device | 1 | Device |