MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE WITH WA00395A; AUTOCLAVABLE 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	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced scope was returned to the olympus service center.The service inspection confirmed the customer¿s reported product problem, the outer tube of the scope was found broken in half.The inspection also noted there is distal end light fiber damage, and moisture under the eyepiece window and laser etching on model ring has minor fading.No image check performed due to condition of the outer tube.The investigation is still ongoing; 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.
Event or Problem Description
Olympus was informed via repair request, the customer straight ocular angle autoclavable rigid ureteroscope ¿is broken in half¿.The customer reported event was found at reprocessing.No death or injury and no impact to patient or other was reported to olympus.
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 definitive root cause of the scope's broken outer tube could not be determined.It is possible that the tube damage occurred due to user error, improper handling, or the application of excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE WITH WA00395A
• Common Device Name: AUTOCLAVABLE 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: 16454632
• Report Number: 9610773-2023-00601
• Device Sequence Number: 5875616
• Product Code: FGB
• UDI-Device Identifier: 04042761063043
• UDI-Public: 04042761063043
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 02/03/2023
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2014
• 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