MAUDE Adverse Event Report: KARL STORZ ENDOVISION VIDEO-URETERO-RENOSCOPE FLEX XC

Model Number	11278VSU
Medical Device Problem Codes	Temperature Problem (3022); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the scope stopped working mid case.The surgeon believes this is because of the incorrect deflection mechanism.The case had to be abandoned as they did not have a spare scope.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
During the technical investigation of the returned product, the following was found: the housing and handle show signs of wear.The shaft is wavy.The distal tip, the vertebrae, the angle cover and the working channel is damaged by laser and the scope is leaking.No angulation up.No image output from the endoscope.The angel cover was cut open during the evaluation.The error described by the customer could be confirmed.This was caused by the laser in the working channel was activated and damaged the sensor.For this reason, a user misuse error is to be considered which led to the missing image.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• Common Device Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 23917743
• Report Number: 1221826-2025-02432
• Device Sequence Number: 9194669
• Product Code: FGB
• UDI-Device Identifier: 04048551344385
• UDI-Public: 04048551344385
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2026

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: 11278VSU
• Device Catalogue Number: 11278VSU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 01/28/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/20/2026; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown