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 Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the insulation of the hook electrode broke off and fell into the operating field during an unspecified procedure.The surgical team retrieved it from the operating field.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields:d8, h2, h3, h4, h6, h11 the device was returned and the reported failure was confirmed.The most probable cause of the complaint is cause not established which indicates that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• 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: 21437803
• Report Number: 9610773-2025-01243
• Device Sequence Number: 4604275
• Product Code: GCJ
• UDI-Device Identifier: 04042761028868
• UDI-Public: 04042761028868
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 06/04/2025

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: A6282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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