MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE; OES ELITE URETEROSCOPES AND ACCESSORIES

Model Number	WA2UR14A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D1: ureteroscope 7.3/10.4 fr.X 430 mm, 5°, angled ocular, 6.4 fr.Channel.The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the stopcock closing nut was missing.No other issues were found.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that the ureteroscope 7.3/10.4 fr.X 430 mm, 5°, angled ocular, 6.4 fr.Channel had the stopcock come off after the first sterilization.The issue was found during the procedure.There were no reports of patient harm.
Event or Problem Description
The intended procedure was completed using the same set of equipment.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Corrected fields: b5 and g2 - health professional is applicable to this event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over one (1) year since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the missing stopcock closing nut occurred due to excessive use.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE
• Common Device Name: OES ELITE URETEROSCOPES AND 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: 18125763
• Report Number: 9610773-2023-03269
• Device Sequence Number: 15348868
• Product Code: FGB
• UDI-Device Identifier: 04042761086363
• UDI-Public: 04042761086363
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K200369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: WA2UR14A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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