MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES ELECTRODE

Model Number	WA22507D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported to olympus after removing the working device from the patient¿s cavity, the surgeon noticed the electrode had broke without doing anything beyond the surgical routine.The malfunction was found during the therapeutic transurethral resection of the prostate (turp).There was no delay, and the procedure was completed with a similar device.There were no reports of patient, user harm or procedure associated with this event.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation and the customer's allegation was not confirmed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct d10.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 cause of the reported issue is most likely due to improper use on the part of the user.In general, the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the instructions for use, a suitable replacement device must be provided during an application.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17405673
• Report Number: 9610773-2023-02023
• Device Sequence Number: 15293093
• Product Code: FAS
• UDI-Device Identifier: 14042761068236
• UDI-Public: 14042761068236
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K100275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: WA22507D
• Device Lot Number: 1000100526
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HF-RESECTION ELECTRODE LOOP, LOT 1000100526
• Patient Sex: Unknown