MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-ELECTRODE, HOOK, 5 X 330 MM; SURG, EN

Model Number	A6282
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to olympus that a hf-electrode had a broken end.The reported issue occurred during reprocessing of the device.No procedure was involved.There was no patient injury or adverse event reported to olympus.
Additional Manufacturer Narrative
The device will not be returned to olympus for evaluation and repair.After the fse (field service engineer) physical check, the reported issue was confirmed damaged (cracked) insulation at the distal end of the tube.All found defect are probably caused by improper customer handling or excessive force.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.A manufacturing and quality control review was performed for the affected serial number without showing any non-conformities or deviations regarding the described issues.Olympus will continue to monitor the field performance of this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the root cause could not be conclusively determined.It is likely the reported event occurred due to improper handling by the user during reprocessing.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-ELECTRODE, HOOK, 5 X 330 MM
• Common Device Name: SURG, EN
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17295328
• Report Number: 9610773-2023-01837
• Device Sequence Number: 12285902
• Product Code: GCJ
• UDI-Device Identifier: 04042761028868
• UDI-Public: 04042761028868
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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
• Device Catalogue Number: A6282
• Device Lot Number: 044386
• Was Device Available for Evaluation?: Yes
• 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: 06/11/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• 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