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
Additional Manufacturer Narrative
This device is pending evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The patients experienced consecutive urethral strictures after transurethral resection in saline (turis) procedures in which the working element (wa22366a) and 24fr resection sheath (a22041a) were used in combination.The procedure was completed using the same device and no additional medical treatment or surgical intervention was required.The physician opinion is that either the handle or the sheath was the cause.Related patient identifiers: (b)(6) working element, active, for resection in saline (wa22366a / 147w0080).(b)(6) working element, active, for resection in saline (wa22366a / 147w0080).(b)(6) resection sheath, 24 fr.(a22041a / 147w0083).(b)(6) resection sheath, 24 fr.(a22041a / 147w0083).This medwatch is for patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on 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 9 years since the subject device was manufactured.Based on the results of the investigation, since the subject device was not returned to olympus for evaluation, the root cause of the reported event could not be determined.This supplemental report includes a correction to d9 and h3 from the initial medwatch.Also, information has been added to h4.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: 18219513
• Report Number: 9610773-2023-03399
• Device Sequence Number: 5672112
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: WA22366A
• Device Lot Number: 147W0080
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: RESECTION SHEATH, 24 FR. A22041A SN:(B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown