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

Model Number	091271-01
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product not returned for evaluation.Conclusion summary: investigational activities suggest multiple root causes could potentially be related to channel blockage issues.In an effort to further investigate the potential root causes, we have initiated r-capa-25-0060.We will continue to track and trend channel blockage issues.This event is filed under internal complaint (b)(4).
Event or Problem Description
It was reported that the issue was that the laser fiber would not pass through the working channel.It was getting stuck at the junction point where the working channel comes in at a 45 degree angle to the straight part of the working channel.It was confirmed that there was no patient injury or impact due to this and the surgeon was able to complete the procedure with another scope.No negative impact in state of health reported.

• 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 avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 24308259
• Report Number: 1221826-2026-00221
• Device Sequence Number: 9679785
• Product Code: FGB
• UDI-Device Identifier: 04048551428016
• UDI-Public: 04048551428016
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: 091271-01
• Device Catalogue Number: 091271-01
• Device Lot Number: 202509221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown