MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Grasping forceps, shark teeth, 5 Fr., semiflexible; Flexible endoscopic grasping forceps, reusable

Model Number	A4825
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that one side of the forceps head was loose and had no screw securing it, rendering the device unusable and preventing the procedure from proceeding during a therapeutic hysteroscopy procedure involving an olympus flexible endoscopic grasping forceps, reusable.The procedure was completed using an olympus backup device.There was no patient injury reported.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.Three attempts were performed to obtain additional information, but no response was received from the customer.

• Brand Name: Grasping forceps, shark teeth, 5 Fr., semiflexible
• Common Device Name: Flexible endoscopic grasping forceps, reusable
• Manufacturer (Section D): Olympus Winter & Ibe GmbH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): Olympus Winter & Ibe GmbH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50884193
• Report Number: 9610773-2026-06351
• Device Sequence Number: 10717965
• Product Code: NWW
• UDI-Device Identifier: 04042761006880
• UDI-Public: 04042761006880
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: 510(k) exemp
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A4825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female