LIGATOR, ESOPHAGEAL
This device is manufactured by BOSTON SCIENTIFIC - CORK, BOSTON SCIENTIFIC - MARLBOROUGH, BOSTON SCIENTIFIC - SPENCER, BOSTON SCIENTIFIC CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Hemorrhage/Blood Loss/Bleeding | 5 | Patient |
| 2024 | Use of Device Problem | 15 | Device |
| 2024 | Premature Activation | 18 | Device |
| 2024 | Material Integrity Problem | 2 | Device |
| 2024 | Material Deformation | 2 | Device |
| 2024 | Human-Device Interface Problem | 5 | Device |
| 2024 | Failure to Fire | 66 | Device |
| 2024 | Difficult or Delayed Positioning | 3 | Device |
| 2024 | Device Difficult to Setup or Prepare | 4 | Device |
| 2024 | Detachment of Device or Device Component | 2 | Device |
| 2024 | Break | 9 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2023 | Use of Device Problem | 8 | Device |
| 2023 | Shipping Damage or Problem | 1 | Device |
| 2023 | Premature Activation | 19 | Device |
| 2023 | Misfire | 1 | Device |
| 2023 | Material Integrity Problem | 8 | Device |
| 2023 | Material Deformation | 2 | Device |
| 2023 | Human-Device Interface Problem | 4 | Device |
| 2023 | Failure to Fire | 82 | Device |
| 2023 | Entrapment of Device | 1 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Difficult or Delayed Positioning | 6 | Device |
| 2023 | Detachment of Device or Device Component | 4 | Device |
| 2023 | Break | 11 | Device |
| 2023 | Activation, Positioning or Separation Problem | 1 | Device |
| 2022 | Use of Device Problem | 12 | Device |
| 2022 | Unsealed Device Packaging | 1 | Device |
| 2022 | Suction Problem | 2 | Device |
| 2022 | Premature Activation | 14 | Device |
| 2022 | Misassembly by Users | 1 | Device |
| 2022 | Material Integrity Problem | 11 | Device |
| 2022 | Material Deformation | 3 | Device |
| 2022 | Human-Device Interface Problem | 2 | Device |
| 2022 | Failure to Fire | 106 | Device |
| 2022 | Difficult to Remove | 2 | Device |
| 2022 | Detachment of Device or Device Component | 2 | Device |
| 2022 | Defective Device | 3 | Device |
| 2022 | Break | 12 | Device |
| 2022 | Activation, Positioning or Separation Problem | 1 | Device |
| 2021 | Defective Device | 1 | Device |
| 2021 | Break | 1 | Device |