Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
5 linked reportsInjury 4Death 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-06 | 0 | 1 |
| 2021-11 | 0 | 2 |
| 2022-01 | 0 | 2 |
| 2022-06 | 0 | 3 |
| 2023-01 | 0 | 3 |
| 2023-10 | 2 | 2 |
| 2024-03 | 1 | 1 |
| 2024-11 | 2 | 2 |
| 2025-05 | 0 | 3 |
Failure-mode summaryAI-generated
5 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-11-18 | 9614641-2024-02095 | Injury | Available | exact di |
| 2024-11-18 | 2429304-2024-0000462 | Injury | Available | exact di |
| 2024-03-01 | 9614641-2024-00547 | Injury | Available | exact di |
| 2023-10-11 | 9614641-2023-01502 | Death | Available | exact di |
| 2023-10-11 | 9614641-2023-01503 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-12-12 | WL | Warning Letter | Olympus Medical Systems Corporation | — |
| 2022-09-09 | OAI | Official action indicated | Olympus Medical Systems Corporation | 1 |
| 2018-03-09 | WL | Warning Letter | Olympus Medical Systems Corporation | — |
| 2015-04-24 | OAI | Official action indicated | Olympus Medical Systems Corporation | 2 |
Similar devices
- "TITANIUM SURGIGAL ASPIRATOR TAPERED 2.5MM - 1/4 DIA - 6.25"" FITS HVE CUTOFF VALV" W.H. Holden, Inc.
- AESCULAP AESCULAP, INC.
- AQUAFIX SYRINGE W.H. Holden, Inc.
- ASPIRATING SYRINGE ASTRA TYPE W.H. Holden, Inc.
- ASPIRATING SYRINGE C-W TYPE SS W.H. Holden, Inc.
- ASSI ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
- Ambler Surgical AMBLER SURGICAL CORP.
- Anodyne Surgical Psi/Eye-Ko, Inc.
- Anodyne Surgical Psi/Eye-Ko, Inc.
- Anodyne Surgical Psi/Eye-Ko, Inc.
- Anodyne Surgical Psi/Eye-Ko, Inc.
- Avalign Avalign Technologies, Inc.
Select up to two to place side-by-side with this device.