MAUDE Adverse Event Report: KARL STORZ ENDOVISION FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM

Model Number	495NA
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
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.

• Brand Name: FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM
• Common Device Name: FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 23729889
• Report Number: 2020550-2025-02265
• Device Sequence Number: 9667637
• Product Code: FCW
• UDI-Device Identifier: 04048551168868
• UDI-Public: 04048551168868
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2025
• Report Date (Section F): 12/05/2025

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: 495NA
• Device Catalogue Number: 495NA
• Device Lot Number: TM13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown