MAUDE Adverse Event Report: KARL STORZ ENDOVISION VIDEO URETERO-RENOSCOPE FLEX-XC1

Model Number	091271-06
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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 "wanted to use a disposable urs, but as soon as it was connected, the system immediately switched off the light and there was no image".No negative impact in state of health reported.
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
Accordingly, we would like to give a summary of our results regarding the reported issue.The evaluation results: the device has been returned for investigation.Functional test has shown no malfunction - product works as intended.Most likely a use-error.The issue could have been caused by a not proper plugged in connector or by use of a 8403zx monitor without the required e-box tc028.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: VIDEO URETERO-RENOSCOPE FLEX-XC1
• Common Device Name: VIDEO URETERO-RENOSCOPE FLEX-XC1
• 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: 23710228
• Report Number: 1221826-2025-02243
• Device Sequence Number: 21501121
• Product Code: FGB
• UDI-Device Identifier: 04048551428009
• UDI-Public: 04048551428009
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K212458
• 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): 04/15/2026

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: 091271-06
• Device Catalogue Number: 091271-06
• Device Lot Number: 500126182
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 04/15/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/02/2026; 04/15/2026
• 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
• Patient Sex: Unknown