MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE 7.3/10.4 FR. X 430 MM, 5°, ANGLED OCULAR, 6.4 FR. CHANNEL

Model Number	WA2UR14A
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, that the tip broke off of the ureteroscope.The issue was found during a therapeutic ureteroscopy procedure.The procedure was completed with a similar non-olympus ureteroscope.No delay was reported.There were no reports of patient harm.No user injury reported.
Additional Manufacturer Narrative
The subject device was returned to an olympus repair center for evaluation and the customer¿s reported problem was confirmed.The device evaluation found that part of the telescope has come out from the distal end tip of the telescope and heavy dent found on the distal end tip, no burns marks noted.In addition, it was noted that a black small ring also came out from the distal end tip.This small black ring was sent by the customer.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.
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.Based on the results of the investigation, the root cause could not be determined.It is likely the reported event occurred due to the use of excessive force from the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE 7.3/10.4 FR. X 430 MM, 5°, ANGLED OCULAR, 6.4 FR. CHANNEL
• Common Device Name: URETEROSCOPE
• 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: 17074693
• Report Number: 9610773-2023-01563
• Device Sequence Number: 6841937
• Product Code: FGB
• UDI-Device Identifier: 04042761086363
• UDI-Public: 04042761086363
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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: WA2UR14A
• Device Catalogue Number: WA2UR14A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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