ULTRASONIC SURGICAL DEVICE
This device is manufactured by GYRUS ACMI, OLYMPUS AMERICA, OLYMPUS CORPORATION OF THE AMERICAS, OLYMPUS MEDICAL SYSTEMS CORP, OLYMPUS MEDICAL SYSTEMS CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Foreign Body In Patient | 1 | Patient |
| 2024 | Separation Problem | 1 | Device |
| 2024 | Peeled/Delaminated | 2 | Device |
| 2024 | Naturally Worn | 2 | Device |
| 2024 | Melted | 2 | Device |
| 2024 | Material Separation | 11 | Device |
| 2024 | Material Rupture | 1 | Device |
| 2024 | Fracture | 1 | Device |
| 2024 | Device Fell | 1 | Device |
| 2024 | Detachment of Device or Device Component | 41 | Device |
| 2024 | Degraded | 1 | Device |
| 2024 | Communication or Transmission Problem | 2 | Device |
| 2024 | Break | 50 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Foreign Body In Patient | 4 | Patient |
| 2023 | Separation Problem | 1 | Device |
| 2023 | Peeled/Delaminated | 6 | Device |
| 2023 | Melted | 1 | Device |
| 2023 | Material Separation | 15 | Device |
| 2023 | Fracture | 26 | Device |
| 2023 | Failure to Eject | 1 | Device |
| 2023 | Detachment of Device or Device Component | 33 | Device |
| 2023 | Degraded | 1 | Device |
| 2023 | Communication or Transmission Problem | 1 | Device |
| 2023 | Break | 51 | Device |
| 2022 | Unspecified Tissue Injury | 3 | Patient |
| 2022 | Unspecified Kidney or Urinary Problem | 3 | Patient |
| 2022 | Abdominal Pain | 2 | Patient |
| 2022 | Peeled/Delaminated | 16 | Device |
| 2022 | Material Split, Cut or Torn | 1 | Device |
| 2022 | Material Separation | 2 | Device |
| 2022 | Loose or Intermittent Connection | 1 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Failure to Deliver Energy | 1 | Device |
| 2022 | Device Remains Activated | 2 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Degraded | 4 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Break | 71 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2021 | Material Separation | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |