MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 7,5 FR. X 430 MM, 7°, 2 CHANNELS, OCULAR ANGLE 45°; RIGID URETEROSCOPE

Model Number	WA02943A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation.The investigation is in process.The olympus service center evaluated the subject device and confirmed the reported event, the device was bent.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported during a procedure, the shaft of the rigid endoscope bent and caused a ureteric partial thickness injury.The surgeon was having difficulty and noted a submucosal flap injury in there ureteral wall and removed then endoscope.After the endoscope was removed, it was identified as bent.The surgeon tried to reinsert the endoscope but could not and completed the procedure with a similar device.There was a 'slight' delay in the procedure to allow for a new endoscope set up.The surgeon placed a stent because of the injury and will follow-up in four weeks to remove the stent.The patient had some hematuria post-operatively which is consistent per the procedure and the injury did not change the patient's course of medication post-operatively.
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.It has been over 12 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the bent scope was caused by the application of excessive force by the user.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of further investigation, it is likely that in addition to application of excessive force by the user, the bent scope was also caused by wear and tear.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE, 7,5 FR. X 430 MM, 7°, 2 CHANNELS, OCULAR ANGLE 45°
• Common Device Name: RIGID URETEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; CA 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15195531
• Report Number: 9610773-2022-00322
• Device Sequence Number: 5633780
• Product Code: FGB
• UDI-Device Identifier: 04042761029537
• UDI-Public: 04042761029537
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA02943A
• Device Catalogue Number: WA02943A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 11/01/2022; 02/06/2023
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 11/23/2022; 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2010
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown