MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, MARYLAND LONG, MONOPOLAR

Model Number	WA69352M
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
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 subject device monopolar jaws were cracked where they meet the sheath.The issue was found during inspection for use.There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated: h2, h3, h6, h11.Corrected: b5 and d2a.The device was not returned.However, the customer allegation of ¿jaws were cracked¿ was confirmed as technical assistance center confirmed the malfunction on inspection.The most probable cause of the complaint is cause not established.Based on the results of the investigation, and since the device was not returned for evaluation, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event due to degradation problem identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the monopolar jaws of the jaws insert hicura were cracked where they meet the sheath.The issue was found during inspection for use.There were no reports of patient involvement.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, MARYLAND LONG, MONOPOLAR
• Common Device Name: JAWS INSERT "HICURA"
• 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: 23539537
• Report Number: 9610773-2025-07025
• Device Sequence Number: 9448837
• Product Code: GEI
• UDI-Device Identifier: 04042761079662
• UDI-Public: 04042761079662
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: WA69352M
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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