MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, CYLINDER, 12° AND 30°, STERILE, SINGLE USE, 12 PCS.; RESECTION ELETRODE

Model Number	A22266C
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the resection electrode tip broke while being ignited and cylinder came off.The cylinder was retrieved.The issue occurred during a therapeutic transurethral resection of the prostate (turp) procedure.There were no reports of patient harm.The intended procedure was completed with a similar device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over one (1) years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The distal end of the electrode is disconnected and shows signs of charring.Olympus was unable to perform a functional inspection as the one side of the insulation was detached from the electrode.The wire at the distal end melted away to the fork insulation.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely due to wear and tear.Additionally, it should be mentioned that the instructions for instructions for use (ifu) note the loop at the distal end of the electrode wears out during use and may break, burn or melt.Olympus will continue to monitor the field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, CYLINDER, 12° AND 30°, STERILE, SINGLE USE, 12 PCS.
• Common Device Name: RESECTION ELETRODE
• 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: 20072661
• Report Number: 9610773-2024-02060
• Device Sequence Number: 2998041
• Product Code: FAS
• UDI-Device Identifier: 14042761036891
• UDI-Public: 14042761036891
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: A22266C
• Device Lot Number: 1000126423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown