MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE; SEMI-RIGID URETEROSCOPE

Model Number	WA29049A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The onsite support specialist reported that during a diagnostic procedure, the customer straight ocular angle, dual channel semi-rigid ureteroscope has a reported broken component defect, ¿damaged lens¿.It was reported the procedure was completed using another similar scope.No death injury or infection and no impact to person or other was reported to olympus.
Additional Manufacturer Narrative
The subject device was returned to the olympus repair center.The repair inspection confirmed the customer¿s reported problem, blurry image identified due to damaged/broken optical fibers at the distal end due to dents and the semi-rigid outer tube is bent.No moisture was observed inside the optical system.The investigation is in progress; therefore, the root cause cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
Additional Manufacturer Narrative
This report is being supplemented to provide results of the investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed and no issues were found related to the reported event.Although a definitive root cause of the defects could not be identified, it was determined that the broken lens was likely caused by excessive force during use by the customer.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

• Brand Name: URETEROSCOPE
• Common Device Name: SEMI-RIGID URETEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16118227
• Report Number: 9610773-2023-00122
• Device Sequence Number: 5654741
• Product Code: FGB
• UDI-Device Identifier: 04042761063043
• UDI-Public: 04042761063043
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K951855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: WA29049A
• Device Catalogue Number: WA29049A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2020
• 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
• Patient Sex: Unknown