MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, WAVE TYPE, MONOPOLAR; WA69334M

Model Number	WA69334M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
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 tip of the device broke off.There was no reported patient harm or injury.Follow up with the customer for more information is pending.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection, and the reported failure was confirmed.As received, the distal end was detached from the rod, and the jaws were misaligned.No signs of debris were observed on the teeth of the jaws.However, the linkage and the proximal end appeared to be in good condition.The jaws opened or closed when the linkage was manually operated, and no parts were found to be missing.A root cause could not be identified.Based on the results of the investigation, it is likely mechanical stress led to the malfunction: should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide correction to h6.
Event or Problem Description
No additional information received form the customer.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, WAVE TYPE, MONOPOLAR
• Common Device Name: WA69334M
• 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: 23789953
• Report Number: 9610773-2025-08212
• Device Sequence Number: 12142995
• Product Code: GEI
• UDI-Device Identifier: 04042761079426
• UDI-Public: 04042761079426
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

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: WA69334M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 03/18/2026; 04/20/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 04/13/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2023
• 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: Unknown