MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, ACTIVE; RIGID ENDOSCOPE WORKING GUIDE

Model Number	WA22066A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urethral Stenosis/Stricture (4501)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the device is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that current leakage was felt in the working element and heat was felt on the telescope during a therapeutic transurethral resection of the prostate.The customer was using a non-olympus cautery.Post surgery, the patient reported urinary incontinence and developed urethral strictures.On (b)(6) 2024, the patient received medical treatment and was prescribed with medication to treat the urinary incontinence due to the strictures.There was no surgical intervention.The patient has recovered and was doing fine in health aspects.
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 evaluated by olympus, and it was observed that the internal electrical contact inside the teflon body is damaged by corrosion, which resulted in poor contact between the electrode and the working element.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, it is likely that the reported event occurred due to the user used a working element damaged by rust.Although the observed device defect is a non-reportable malfunction, the component failure likely caused and/or contributed to the reported event.Olympus will continue to monitor field performance for this device.

• Brand Name: WORKING ELEMENT, ACTIVE
• Common Device Name: RIGID ENDOSCOPE WORKING GUIDE
• 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: 20268536
• Report Number: 9610773-2024-02282
• Device Sequence Number: 7240850
• Product Code: GCP
• UDI-Device Identifier: 04042761051613
• UDI-Public: 04042761051613
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: WA22066A
• Device Lot Number: W2105-4074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2024
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS CAUTERY; UNKNOWN TELESCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male