MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE

Model Number	WA22351C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus, the electrode roller ball becoming loose during what is presumed to be a urologic procedure.The roller ball was not recovered from the male patient.Additional information was requested; however, no further information was provided regarding the patient nor the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the reported failure was confirmed.The investigation findings are as follows: 1.The electrode wire (which leads the roller) was broken at both sides.2.Signs of thermal stress on the insulation sleeves.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the cause of the reported issue is likely due to wear and tear.During use, the distal end of the electrode wears off and can break, burn, or melt.Furthermore, both the roller and wire fell into the patient¿s body, and it is likely that the fragments were flushed out of the patient¿s body.However, details regarding flushing liquid was not provided.This supplemental report includes an update to h3 from the initial medwatch.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE
• Common Device Name: HF-RESECTION 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, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18378032
• Report Number: 9610773-2023-03732
• Device Sequence Number: 7617530
• Product Code: FAS
• UDI-Device Identifier: 14042761051719
• UDI-Public: 14042761051719
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

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: WA22351C
• Device Lot Number: 1000121217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male