MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-ELECTRODE, HOOK, 5 X 330 MM; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, REUSABLE

Model Number	A6282
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
During a laparoscopic cholecystectomy, the tip of the hook electrode broke.No harm reported.

• Brand Name: HF-ELECTRODE, HOOK, 5 X 330 MM
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, REUSABLE
• 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: 25303165
• Report Number: 9610773-2026-04103
• Device Sequence Number: 15779731
• Product Code: GCJ
• UDI-Device Identifier: 04042761028868
• UDI-Public: 04042761028868
• Combination Product (Y/N): N
• PMA/510(K) Number: K923982
• 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
• Report Date (Section B): 05/27/2026

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: A6282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown