MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 430, CROCEOLMI, MONOPOLAR; WA69320L

Model Number	WA69320L
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
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 during a laparoscopic cystectomy, approximately 5 mm of the lower portion of the tip of this forceps was damaged and fell off into the abdominal lumen.Other forceps was used to successfully retrieve the part that fell off.The procedure was then completed.There were no further reports of patient harm.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: d9, h3, h4 and h6.The device was returned to olympus for inspection and the reported failure was confirmed.A visual inspection revealed that the tip of the forceps was broken and the gripping surface was scratched.Based on the results of the investigation, the definitive root cause of the reported issue could not be determined.The likely cause of this event was due to component failure.The cause of the breakage of the forceps tip, discovered through visual inspection, could not be identified, but there were scratches on the gripping surface of the forceps, which suggests the possibility of overload, such as gripping other equipment.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 430, CROCEOLMI, MONOPOLAR
• Common Device Name: WA69320L
• 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: 24240650
• Report Number: 9610773-2026-00683
• Device Sequence Number: 21389695
• Product Code: GEI
• UDI-Device Identifier: 04042761079280
• UDI-Public: 04042761079280
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA69320L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown