MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	WA22366A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urethral Stenosis/Stricture (4501)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that a series of patients developed urethral strictures following transurethral resection in saline (turis) procedures using a combination of this rigid endoscope working guide and resection sheath.Two patients have been confirmed so far, but there may be more.There was an opinion from the physician that the cause was either the handle or the sheath.The devices were inspected prior to use.No errors during procedure.Additional information has been requested.There were no reports of further patient or user harm associated with this event.Patient identifiers: (b)(6) - patient 1 rigid endoscope working guide (b)(6) - patient 1 resection sheath (b)(6)- patient 2 rigid endoscope working guide (b)(6) - patient 2 resection sheath this report is for (b)(6).
Additional Manufacturer Narrative
To date, this device has not been returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation and correction to the initial with information inadvertently left out.Additionally, to provide a correction to the initial (d4-lot number, d10-lot number, and h3).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was not confirmed.The complete evaluation results are as followed: no abnormalities such as damage or corrosion were found in the received handle and inner sheath.Olympus confirmed that it was combined with the electrodes for examination and the high-frequency cauterization power supply esg-400, and it was confirmed that the output was normal.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, no abnormality were found in the received product.Therefore, a specific root cause of the urethral strictures following transurethral resection in saline (turis) procedures could not be determined from the information received.Olympus will continue to monitor field performance for this device.

• Brand Name: WORKING ELEMENT, ACTIVE, FOR RESECTION IN SALINE
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• 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: 17093394
• Report Number: 9610773-2023-01597
• Device Sequence Number: 1894583
• Product Code: KNS
• UDI-Device Identifier: 04042761066235
• UDI-Public: 04042761066235
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 09/21/2023

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: WA22366A
• Device Catalogue Number: WA22366A
• Device Lot Number: 085W-0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• 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: A22041A UNKNOWN LOT NUMBER; A22041A: LOT NUMBER 132W-0002
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown