LITHOTRIPTOR, BILIARY MECHANICAL
This device is manufactured by BOSTON SCIENTIFIC - SPENCER, BOSTON SCIENTIFIC CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Foreign Body In Patient | 1 | Patient |
| 2024 | Use of Device Problem | 5 | Device |
| 2024 | Separation Failure | 1 | Device |
| 2024 | Premature Activation | 3 | Device |
| 2024 | Material Split, Cut or Torn | 1 | Device |
| 2024 | Material Deformation | 1 | Device |
| 2024 | Failure to Disconnect | 1 | Device |
| 2024 | Difficult to Open or Close | 3 | Device |
| 2024 | Detachment of Device or Device Component | 2 | Device |
| 2024 | Break | 16 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2023 | Use of Device Problem | 7 | Device |
| 2023 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2023 | Separation Failure | 5 | Device |
| 2023 | Premature Activation | 2 | Device |
| 2023 | Material Twisted/Bent | 3 | Device |
| 2023 | Material Split, Cut or Torn | 2 | Device |
| 2023 | Material Deformation | 15 | Device |
| 2023 | Leak/Splash | 1 | Device |
| 2023 | Difficult to Open or Close | 9 | Device |
| 2023 | Detachment of Device or Device Component | 7 | Device |
| 2023 | Deformation Due to Compressive Stress | 4 | Device |
| 2023 | Break | 20 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Unintended Movement | 1 | Device |
| 2022 | Separation Failure | 4 | Device |
| 2022 | Premature Activation | 3 | Device |
| 2022 | Material Split, Cut or Torn | 5 | Device |
| 2022 | Material Deformation | 14 | Device |
| 2022 | Difficult to Open or Close | 6 | Device |
| 2022 | Difficult to Advance | 1 | Device |
| 2022 | Detachment of Device or Device Component | 12 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Break | 32 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2019 | Use of Device Problem | 1 | Device |
| 2019 | Separation Failure | 8 | Device |
| 2019 | Premature Activation | 7 | Device |
| 2019 | Material Split, Cut or Torn | 4 | Device |
| 2019 | Material Deformation | 5 | Device |
| 2019 | Entrapment of Device | 1 | Device |
| 2019 | Difficult to Open or Close | 2 | Device |
| 2019 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2019 | Detachment of Device or Device Component | 3 | Device |
| 2019 | Break | 26 | Device |
| 2018 | Use of Device Problem | 1 | Device |
| 2018 | Tear, Rip or Hole in Device Packaging | 3 | Device |
| 2018 | Separation Failure | 4 | Device |
| 2018 | Premature Activation | 4 | Device |
| 2018 | Material Twisted/Bent | 1 | Device |
| 2018 | Material Deformation | 8 | Device |
| 2018 | Difficult to Open or Close | 4 | Device |
| 2018 | Detachment of Device or Device Component | 10 | Device |
| 2018 | Deformation Due to Compressive Stress | 1 | Device |
| 2018 | Defective Device | 3 | Device |
| 2018 | Break | 13 | Device |
| 2017 | Unsealed Device Packaging | 1 | Device |
| 2017 | Separation Failure | 4 | Device |
| 2017 | Material Deformation | 31 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Detachment of Device or Device Component | 9 | Device |
| 2017 | Detachment Of Device Component | 1 | Device |
| 2017 | Break | 29 | Device |
| 2016 | Separation Failure | 4 | Device |
| 2016 | Material Deformation | 29 | Device |
| 2016 | Device Operates Differently Than Expected | 1 | Device |
| 2016 | Detachment of Device or Device Component | 4 | Device |
| 2016 | Detachment Of Device Component | 2 | Device |
| 2016 | Break | 18 | Device |
| 2015 | Separation Failure | 2 | Device |
| 2015 | Material Deformation | 6 | Device |
| 2015 | Detachment Of Device Component | 1 | Device |
| 2015 | Break | 6 | Device |
| 2014 | Separation Failure | 8 | Device |
| 2014 | Material Deformation | 1 | Device |
| 2014 | Detachment of Device or Device Component | 1 | Device |
| 2014 | Detachment Of Device Component | 7 | Device |
| 2014 | Break | 19 | Device |
| 2013 | Break | 1 | Device |