MAUDE Adverse Event Report: KARL STORZ ENDOVISION LIGHT CABLE ASSEMBLY, 4.8 MM X 2500MM

Model Number	495NCS
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
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: "whilst operating, the fiber optic cable fall off/come loose from the light post on the telescope.There was no harm to the patient or user".No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the customer's statement "the fiber optic cable will fall off/come loose from the light post on the telescope" cannot be confirmed.No damage to the light cable or the optical connection point could be detected.The cable corresponds to the currently valid specifications.The light cable shows normal wear and tear corresponding to the application without affecting the function.The most probable root cause of the cable falling off is that the optics are not connected correctly, which could cause the cable to suddenly come off.We expressly point it out in the ifu associated with the cable.Internal karl storz reference number: (b)(4).

• Brand Name: LIGHT CABLE ASSEMBLY, 4.8 MM X 2500MM
• Common Device Name: LIGHT CABLE ASSEMBLY, 4.8 MM X 2500MM
• 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: 21426208
• Report Number: 1221826-2025-00266
• Device Sequence Number: 18090921
• Product Code: FCW
• UDI-Device Identifier: 04048551001141
• UDI-Public: 04048551001141
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 495NCS
• Device Catalogue Number: 495NCS
• Device Lot Number: ZT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/17/2025
• 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