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

Model Number	WA69334M
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	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic laparoscopic appendectomy procedure, the wavy grasper tip broke off in the peritoneal space of the patient.It was not noticed immediately.The scrub nurse later noticed that the tip was missing from the instrument.The surgeon went into the peritoneal space with another instrument, located the wavy grasper tip and removed it from the patient.The procedure was completed using a backup device.There were no further reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: d9, h6 and h11.The device was not returned to olympus for inspection.However, the reported failure was confirmed based on the images provided by the customer, which demonstrate that the forceps were broken at the tip and were inside the patient.Based on the results of the investigation, the definitive root cause of the reported issue could not be determined.The most probable cause of the complaint is categorized as cause not established, as the investigation findings do not provide a definitive conclusion about the cause of the reported issue.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from 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 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22334269
• Report Number: 9610773-2025-04178
• Device Sequence Number: 18383242
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: WA69334M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown