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

Model Number	091279-06
Medical Device Problem Codes	Mechanical Jam (2983); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, a bilateral flexible ureteroscopy was performed using a disposable flexible ureteroscope.During insertion, the cable on the equipment stopped deflecting and the surgery had to be suspended.Another piece of equipment was brought to the table, but the cable on that equipment also broke.This delayed the procedure and another piece of equipment had to be set up.On (b)(6) 2025 it was mentioned by the customer that the whole procedure had to be cancelled after the above-mentioned event.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
Additional information was received in section b5 correction in reported device information in section d and g4 the event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
On (b)(6) 2025 additional information was received that the confirmation was received that there was no abortion of the surgery.The device was changed, and the surgery was completed.
Additional Manufacturer Narrative
Investigation: accordingly, we would like to give a summary of our results regarding the reported issue.Two endoscopes have been returned for investigation.The lack of deflection capability can be confirmed.On both endoscopes, the steering wires have been ruptured in the same area - the appearance of the ruptured area indicates a mechanical overload.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
• MDR Report Key: 23729549
• Report Number: 1221826-2025-02265
• Device Sequence Number: 21486714
• Product Code: FGB
• UDI-Device Identifier: 04048551428030
• UDI-Public: 04048551428030
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2026

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: 091279-06
• Device Catalogue Number: 091279-06
• Device Lot Number: 500124038
• 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: 12/09/2025; 04/13/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/16/2025; 04/14/2026
• 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