INSTRUMENT, ULTRASONIC SURGICAL
This device is manufactured by ETHICON, ETHICON ENDO-SURGERY, ETHICON ENDO-SURGERY SA DE CV PLANTA II, JOHNSON AND JOHNSON / ETHICON ENDO-SURGERY, STRYKER SUSTAINABILITY SOLUTIONS and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Burn(s) | 1 | Patient |
| 2024 | Tear, Rip or Hole in Device Packaging | 3 | Device |
| 2024 | Smoking | 1 | Device |
| 2024 | Self-Activation or Keying | 2 | Device |
| 2024 | Protective Measures Problem | 2 | Device |
| 2024 | Noise, Audible | 5 | Device |
| 2024 | Material Separation | 133 | Device |
| 2024 | Material Integrity Problem | 11 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Inappropriate or Unexpected Reset | 10 | Device |
| 2024 | Human-Device Interface Problem | 1 | Device |
| 2024 | Failure to Read Input Signal | 50 | Device |
| 2024 | Difficult or Delayed Activation | 22 | Device |
| 2024 | Detachment of Device or Device Component | 53 | Device |
| 2024 | Delivered as Unsterile Product | 3 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2024 | Activation, Positioning or Separation Problem | 10 | Device |
| 2023 | Burn(s) | 1 | Patient |
| 2023 | Tear, Rip or Hole in Device Packaging | 1 | Device |
| 2023 | Protective Measures Problem | 6 | Device |
| 2023 | Noise, Audible | 5 | Device |
| 2023 | Material Separation | 82 | Device |
| 2023 | Material Integrity Problem | 27 | Device |
| 2023 | Insufficient Information | 3 | Device |
| 2023 | Inappropriate or Unexpected Reset | 23 | Device |
| 2023 | Fracture | 1 | Device |
| 2023 | Failure to Read Input Signal | 88 | Device |
| 2023 | Excessive Heating | 2 | Device |
| 2023 | Difficult or Delayed Activation | 31 | Device |
| 2023 | Detachment of Device or Device Component | 67 | Device |
| 2023 | Break | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Activation, Positioning or Separation Problem | 14 | Device |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Tear, Rip or Hole in Device Packaging | 2 | Device |
| 2022 | Protective Measures Problem | 3 | Device |
| 2022 | Noise, Audible | 1 | Device |
| 2022 | No Apparent Adverse Event | 1 | Device |
| 2022 | Melted | 2 | Device |
| 2022 | Mechanical Problem | 2 | Device |
| 2022 | Material Separation | 48 | Device |
| 2022 | Material Integrity Problem | 12 | Device |
| 2022 | Key or Button Unresponsive/not Working | 1 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Inappropriate or Unexpected Reset | 4 | Device |
| 2022 | Human-Device Interface Problem | 1 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Failure to Read Input Signal | 60 | Device |
| 2022 | Failure to Cycle | 1 | Device |
| 2022 | Difficult or Delayed Activation | 8 | Device |
| 2022 | Detachment of Device or Device Component | 43 | Device |
| 2022 | Delivered as Unsterile Product | 4 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Activation, Positioning or Separation Problem | 10 | Device |
| 2021 | Protective Measures Problem | 1 | Device |
| 2021 | Failure to Read Input Signal | 1 | Device |
| 2020 | Patient Device Interaction Problem | 1 | Device |