STAPLE, IMPLANTABLE
This device is manufactured by ETHICON, ETHICON ENDO-SURGERY.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Hemorrhage/Blood Loss/Bleeding | 3 | Patient |
| 2024 | Fistula | 2 | Patient |
| 2024 | Positioning Failure | 1 | Device |
| 2024 | Patient Device Interaction Problem | 2 | Device |
| 2024 | Noise, Audible | 3 | Device |
| 2024 | No Apparent Adverse Event | 1 | Device |
| 2024 | Mechanical Jam | 1 | Device |
| 2024 | Material Integrity Problem | 3 | Device |
| 2024 | Firing Problem | 1 | Device |
| 2024 | Failure to Form Staple | 2 | Device |
| 2024 | Failure to Fire | 9 | Device |
| 2024 | Difficult to Open or Close | 8 | Device |
| 2024 | Detachment of Device or Device Component | 1 | Device |
| 2024 | Activation Failure | 1 | Device |
| 2023 | Unspecified Tissue Injury | 1 | Patient |
| 2023 | Peritonitis | 2 | Patient |
| 2023 | Nausea | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Fever | 2 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Noise, Audible | 3 | Device |
| 2023 | Material Integrity Problem | 10 | Device |
| 2023 | Firing Problem | 2 | Device |
| 2023 | Failure to Form Staple | 3 | Device |
| 2023 | Failure to Fire | 18 | Device |
| 2023 | Failure to Cut | 2 | Device |
| 2023 | Difficult to Open or Close | 13 | Device |
| 2023 | Component or Accessory Incompatibility | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Nausea | 4 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 4 | Patient |
| 2022 | Dizziness | 4 | Patient |
| 2022 | Positioning Failure | 2 | Device |
| 2022 | Physical Resistance/Sticking | 1 | Device |
| 2022 | Patient Device Interaction Problem | 2 | Device |
| 2022 | Noise, Audible | 5 | Device |
| 2022 | No Apparent Adverse Event | 7 | Device |
| 2022 | Mechanical Jam | 2 | Device |
| 2022 | Material Integrity Problem | 5 | Device |
| 2022 | Firing Problem | 2 | Device |
| 2022 | Failure to Form Staple | 10 | Device |
| 2022 | Failure to Fire | 22 | Device |
| 2022 | Failure to Cut | 4 | Device |
| 2022 | Energy Output Problem | 1 | Device |
| 2022 | Ejection Problem | 4 | Device |
| 2022 | Difficult to Open or Close | 13 | Device |
| 2022 | Difficult or Delayed Activation | 2 | Device |
| 2022 | Delivered as Unsterile Product | 1 | Device |
| 2022 | Component or Accessory Incompatibility | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2022 | Activation, Positioning or Separation Problem | 1 | Device |
| 2019 | Use of Device Problem | 2 | Device |
| 2019 | Unsealed Device Packaging | 1 | Device |
| 2019 | Separation Failure | 1 | Device |
| 2019 | Self-Activation or Keying | 1 | Device |
| 2019 | Retraction Problem | 6 | Device |
| 2019 | Power Problem | 1 | Device |
| 2019 | Positioning Problem | 1 | Device |
| 2019 | Physical Resistance/Sticking | 8 | Device |
| 2019 | Overheating of Device | 1 | Device |
| 2019 | Output Problem | 1 | Device |
| 2019 | Obstruction of Flow | 1 | Device |
| 2019 | Noise, Audible | 5 | Device |
| 2019 | Misfire | 5 | Device |
| 2019 | Mechanics Altered | 1 | Device |
| 2019 | Mechanical Problem | 6 | Device |
| 2019 | Mechanical Jam | 10 | Device |
| 2019 | Material Twisted/Bent | 4 | Device |
| 2019 | Material Separation | 1 | Device |
| 2019 | Material Fragmentation | 2 | Device |
| 2019 | Material Disintegration | 1 | Device |
| 2019 | Material Deformation | 2 | Device |
| 2019 | Loss of Power | 1 | Device |
| 2019 | Loose or Intermittent Connection | 1 | Device |
| 2019 | Fitting Problem | 2 | Device |
| 2019 | Firing Problem | 8 | Device |
| 2019 | Failure to Form Staple | 34 | Device |
| 2019 | Failure to Fire | 12 | Device |
| 2019 | Failure to Cut | 3 | Device |
| 2019 | Failure to Align | 6 | Device |
| 2019 | Dull, Blunt | 1 | Device |
| 2019 | Difficult to Remove | 1 | Device |
| 2019 | Difficult to Open or Close | 20 | Device |
| 2019 | Device Remains Activated | 1 | Device |
| 2019 | Device Displays Incorrect Message | 1 | Device |
| 2019 | Device Dislodged or Dislocated | 1 | Device |
| 2019 | Device Alarm System | 1 | Device |
| 2019 | Detachment of Device or Device Component | 2 | Device |
| 2019 | Contamination /Decontamination Problem | 1 | Device |
| 2019 | Complete Blockage | 1 | Device |
| 2019 | Break | 4 | Device |
| 2019 | Battery Problem | 3 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
| 2019 | Activation, Positioning or Separation Problem | 2 | Device |
| 2019 | Activation Problem | 2 | Device |
| 2018 | Structural Problem | 1 | Device |
| 2018 | Retraction Problem | 9 | Device |
| 2018 | Positioning Problem | 1 | Device |
| 2018 | Positioning Failure | 5 | Device |
| 2018 | Physical Resistance/Sticking | 3 | Device |
| 2018 | Peeled/Delaminated | 1 | Device |
| 2018 | Packaging Problem | 1 | Device |
| 2018 | Noise, Audible | 6 | Device |
| 2018 | Misfire | 9 | Device |
| 2018 | Migration or Expulsion of Device | 1 | Device |
| 2018 | Mechanical Problem | 11 | Device |
| 2018 | Mechanical Jam | 13 | Device |
| 2018 | Material Twisted/Bent | 6 | Device |
| 2018 | Material Integrity Problem | 1 | Device |
| 2018 | Material Disintegration | 1 | Device |
| 2018 | Loss of Power | 2 | Device |
| 2018 | Leak/Splash | 5 | Device |
| 2018 | Insufficient Information | 1 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2018 | Gas/Air Leak | 1 | Device |
| 2018 | Fluid/Blood Leak | 2 | Device |
| 2018 | Fitting Problem | 3 | Device |
| 2018 | Firing Problem | 31 | Device |
| 2018 | Failure to Form Staple | 68 | Device |
| 2018 | Failure to Fire | 7 | Device |
| 2018 | Failure to Cut | 5 | Device |
| 2018 | Failure to Auto Stop | 1 | Device |
| 2018 | Failure to Align | 1 | Device |
| 2018 | Failure to Advance | 2 | Device |
| 2018 | Failure To Adhere Or Bond | 1 | Device |
| 2018 | Entrapment of Device | 1 | Device |
| 2018 | Disconnection | 1 | Device |
| 2018 | Disassembly | 1 | Device |
| 2018 | Difficult to Remove | 1 | Device |
| 2018 | Difficult to Open or Close | 17 | Device |
| 2018 | Difficult to Insert | 1 | Device |
| 2018 | Device Packaging Compromised | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 11 | Device |
| 2018 | Device Markings/Labelling Problem | 1 | Device |
| 2018 | Device Inoperable | 4 | Device |
| 2018 | Device Dislodged or Dislocated | 1 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2018 | Detachment Of Device Component | 4 | Device |
| 2018 | Defective Device | 6 | Device |
| 2018 | Defective Component | 1 | Device |
| 2018 | Crack | 3 | Device |
| 2018 | Component Missing | 2 | Device |
| 2018 | Component Falling | 1 | Device |
| 2018 | Complete Blockage | 1 | Device |
| 2018 | Break | 10 | Device |
| 2018 | Blocked Connection | 2 | Device |
| 2018 | Bent | 2 | Device |
| 2018 | Battery Problem | 3 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2018 | Activation, Positioning or Separation Problem | 2 | Device |
| 2017 | Structural Problem | 1 | Device |
| 2017 | Sticking | 2 | Device |
| 2017 | Retraction Problem | 2 | Device |
| 2017 | Positioning Failure | 4 | Device |
| 2017 | Noise, Audible | 1 | Device |
| 2017 | Misfire | 4 | Device |
| 2017 | Mechanical Jam | 5 | Device |
| 2017 | Leak/Splash | 3 | Device |
| 2017 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2017 | Hole In Material | 1 | Device |
| 2017 | Fluid/Blood Leak | 4 | Device |
| 2017 | Failure to Form Staple | 10 | Device |
| 2017 | Failure to Fire | 14 | Device |
| 2017 | Difficult to Remove | 1 | Device |
| 2017 | Difficult to Open or Close | 1 | Device |
| 2017 | Device Operates Differently Than Expected | 10 | Device |
| 2017 | Device Inoperable | 3 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2017 | Crack | 3 | Device |
| 2017 | Break | 2 | Device |
| 2017 | Bent | 2 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2017 | Activation, Positioning or Separation Problem | 2 | Device |
| 2016 | Torn Material | 1 | Device |
| 2016 | Separation Failure | 1 | Device |
| 2016 | Retraction Problem | 1 | Device |
| 2016 | Misfire | 2 | Device |
| 2016 | Mechanical Problem | 1 | Device |
| 2016 | Mechanical Jam | 1 | Device |
| 2016 | Leak/Splash | 1 | Device |
| 2016 | Failure to Fire | 4 | Device |
| 2016 | Difficult to Insert | 1 | Device |