MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE; URETERORENOSCOPE

Model Number	WA29049A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The evaluation found a bent outer tube, and a spot on the optical.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, at the outpatient surgery unit, during procedure, it was reported that the device-ureteroscope, 6,4/7,8 fr.X 330 mm, 7°, straight ocular angle, 4,2 fr.Channel, with wa00395a was bent at the end of the procedure when removing the scope.The procedure was ureteroscopy laser lithotripsy stenting undertaken and completed with the same device.The procedure was prolonged by 15 mins.Though there was a delay, this delay was reported to be a short one.There were no reports of patient harm or clinical impact associated with the reported event.No medical intervention was undertaken to preclude permanent harm/injury to the patient.There is no evidence of any serious deterioration in the state of health of the patient.Also, no indication of any life-threatening event occurred during the procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.New information added to the following fields: 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.The device was returned, and an evaluation was completed for it.During inspection, olympus confirmed the reported event.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely the event occurred due excessive use.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE
• Common Device Name: URETERORENOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17875829
• Report Number: 9610773-2023-02817
• Device Sequence Number: 14549609
• Product Code: FGB
• UDI-Device Identifier: 04042761063043
• UDI-Public: 04042761063043
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: WA29049A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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