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Richard Wolf GmbH · Model 8988231 · UDI-DI 04055207023716
10
510(k) clearances
8,394
Adverse events (41 deaths)
14
Recalls
134
Facilities
Description
WORKING INSERT FOR HYSTEROSCOPE 21FR with deflection lever, working channel 7Fr, compatible with outer sheath 8988031 for diagnostic hysteroscopy, and telescopes Ø 4mm, with Luer connection, bayonet-cap, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | Karl Storz Endoscopy | Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could |
| 2025-11-11 | Olympus Corporation of the Americas | Complaints of the ceramic tip of the resection sheath breaking have been received. |
| 2025-06-18 | Olympus Corporation of the Americas | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU). |
| 2025-06-18 | Olympus Corporation of the Americas | Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU). |
| 2024-04-18 | Olympus Corporation of the Americas | The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image. |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endo |
| 2023-07-20 | Olympus Corporation of the Americas | IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes. |
| 2023-06-23 | Scholly Fiberoptic Gmbh | There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occu |
| 2022-06-07 | Covidien Llc | Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.