MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, CROCEOLMI, MONOPOLAR; WA69320M

Model Number	WA69320M
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failure was confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: a deformation related component failure.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that the jaws insert had the upper edge of the distal end bite area slightly protruding.The poor engagement of the grip section was presumed to be due to deformation of the upper side of the distal end.The issue occurred during reprocessing.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to the product serial/lot number (d4 device is lot coded) and update to the product return date (d9).
Event or Problem Description
There is no new information provided by the customer.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, CROCEOLMI, MONOPOLAR
• Common Device Name: WA69320M
• 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 ; 5082077661
• MDR Report Key: 24105062
• Report Number: 9610773-2026-00409
• Device Sequence Number: 18703038
• Product Code: GEI
• UDI-Device Identifier: 04042761079297
• UDI-Public: 04042761079297
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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: WA69320M
• Device Lot Number: 19403-008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 02/07/2026; 02/27/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/03/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2019
• 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: Unknown