MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, STRAIGHT OCULAR ANGLE, 4,2 FR. CHANNEL

Model Number	WA29048A
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	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6) healthcare corporation.The device was returned to olympus for evaluation and the evaluation found moisture under the distal cover glass, a bent outer tube, dents on the distal end, moisture under the cover glass on the objective window, a missing color ring on the eyepiece unit, and a shadow on the image due to a bent outer tube.The investigation is ongoing.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, the eyepiece came off the ureteroscope.The issue was found during reprocessing.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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 8 years since the subject device was manufactured.The reportable malfunction was confirmed.Based on the results of the investigation, a definitive root cause for the events could not be determined.However, the reported issue is most likely due to excessive use.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE, 6,4/7,8 FR. X 430 MM, 7°, STRAIGHT OCULAR ANGLE, 4,2 FR. CHANNEL
• Common Device Name: URETEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 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: 18481089
• Report Number: 9610773-2024-00133
• Device Sequence Number: 6594325
• Product Code: FGB
• UDI-Device Identifier: 04042761062510
• UDI-Public: 04042761062510
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• 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: WA29048A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2015
• 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