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

Model Number	A6293
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the electrode hook was damaged.The issue occurred during reprocessing.There were no patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was able to be confirmed.During the evaluation it was observed that the shaft was bent due to excessive force by the user.Additionally, it was observed that there was a crack in the ceramic insulation.The cause of this crack could not be determined however, it¿s a possibility that the electrode was pre-damaged due to improper handling or caused by wear and tear.This report is also being supplemented to provide additional information based on the legal manufacturer's final investigation.Section h3 was updated with additional information that was received about the event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the cracked ceramic insulation and bent shaft could but be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-ELECTRODE, HOOK LONG, WITH SUCTION CHANNEL, 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19606493
• Report Number: 9610773-2024-01539
• Device Sequence Number: 15042683
• Product Code: GCJ
• UDI-Device Identifier: 04042761009980
• UDI-Public: 04042761009980
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K923982
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: A6293
• Device Lot Number: 215012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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
• Patient Sex: Unknown