ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
This device is manufactured by BOSTON SCIENTIFIC CORPORATION, GETINGE / MAQUET CARDIOVASCULAR, MAQUET, MAQUET CARDIOVASCULAR, MAQUET GETINGE GROUP.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 25 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 3 | Patient |
| 2024 | Foreign Body In Patient | 4 | Patient |
| 2024 | Thermal Decomposition of Device | 1 | Device |
| 2024 | Poor Quality Image | 2 | Device |
| 2024 | Peeled/Delaminated | 14 | Device |
| 2024 | Packaging Problem | 2 | Device |
| 2024 | Overheating of Device | 1 | Device |
| 2024 | No Flow | 2 | Device |
| 2024 | No Apparent Adverse Event | 16 | Device |
| 2024 | Melted | 2 | Device |
| 2024 | Mechanical Problem | 6 | Device |
| 2024 | Material Twisted/Bent | 24 | Device |
| 2024 | Material Rupture | 1 | Device |
| 2024 | Material Deformation | 7 | Device |
| 2024 | Intermittent Continuity | 7 | Device |
| 2024 | Insufficient Information | 2 | Device |
| 2024 | Inflation Problem | 2 | Device |
| 2024 | Improper Flow or Infusion | 14 | Device |
| 2024 | Fitting Problem | 2 | Device |
| 2024 | Failure to Deliver Energy | 2 | Device |
| 2024 | Failure to Cut | 11 | Device |
| 2024 | Environmental Particulates | 8 | Device |
| 2024 | Electrical /Electronic Property Problem | 8 | Device |
| 2024 | Device Remains Activated | 7 | Device |
| 2024 | Device Emits Odor | 1 | Device |
| 2024 | Contamination /Decontamination Problem | 1 | Device |
| 2024 | Contamination | 1 | Device |
| 2024 | Connection Problem | 5 | Device |
| 2024 | Component Missing | 1 | Device |
| 2024 | Break | 18 | Device |
| 2023 | Rash | 1 | Patient |
| 2023 | Laceration(s) | 1 | Patient |
| 2023 | Insufficient Information | 8 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Burn(s) | 2 | Patient |
| 2023 | Poor Quality Image | 1 | Device |
| 2023 | Peeled/Delaminated | 14 | Device |
| 2023 | Particulates | 1 | Device |
| 2023 | No Apparent Adverse Event | 2 | Device |
| 2023 | Mechanical Problem | 3 | Device |
| 2023 | Material Twisted/Bent | 16 | Device |
| 2023 | Material Rupture | 2 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Intermittent Continuity | 3 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Infusion or Flow Problem | 1 | Device |
| 2023 | Inflation Problem | 1 | Device |
| 2023 | Improper Flow or Infusion | 3 | Device |
| 2023 | Failure to Deliver Energy | 8 | Device |
| 2023 | Failure to Cut | 4 | Device |
| 2023 | Environmental Particulates | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 15 | Device |
| 2023 | Device Remains Activated | 2 | Device |
| 2023 | Detachment of Device or Device Component | 2 | Device |
| 2023 | Contamination /Decontamination Problem | 1 | Device |
| 2023 | Connection Problem | 4 | Device |
| 2023 | Component Missing | 2 | Device |
| 2023 | Burst Container or Vessel | 1 | Device |
| 2023 | Break | 5 | Device |
| 2022 | Smoking | 1 | Device |
| 2022 | Peeled/Delaminated | 16 | Device |
| 2022 | No Apparent Adverse Event | 1 | Device |
| 2022 | Melted | 5 | Device |
| 2022 | Material Twisted/Bent | 14 | Device |
| 2022 | Material Rupture | 1 | Device |
| 2022 | Intermittent Continuity | 1 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Improper Flow or Infusion | 3 | Device |
| 2022 | Fitting Problem | 1 | Device |
| 2022 | Failure to Deliver Energy | 4 | Device |
| 2022 | Failure to Cut | 5 | Device |
| 2022 | Environmental Particulates | 1 | Device |
| 2022 | Electrical /Electronic Property Problem | 8 | Device |
| 2022 | Device Remains Activated | 1 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Contamination /Decontamination Problem | 1 | Device |
| 2022 | Break | 7 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Poor Quality Image | 1 | Device |