MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE, 250 CM, Ø4.8 MM

Model Number	495NCSC
Medical Device Problem Codes	Decoupling (1145); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the end of the cables falls off of them as a result of a deficiency.No negative impact in state of health reported.Cross reference the followig medwatch numbers: 9510617-2025-01588, 9610617-2025-01589 and 9610617-2025-01582.
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the device was sent to karl storz customer service for inspection.During the technical inspection, the fault description provided by the customer, "the end of the cable falls off," was confirmed.The large ring nut on the optical connector has come loose and the knurled nut has fallen off.The knurled nut shows normal signs of wear on the surface.Since the small, knurled nut is stuck, we assume that mechanical damage or external mechanical influence caused the large ring nut to loosen and the optical connector to fall apart.However, the large ring nut that is still in place shows no mechanical damage.Residue is visible on the ring nut.The defect found is not due to a production/manufacturing error.No further measures will be taken.The above investigations did not reveal any cause related to the labeling, the device, or its history.All production-related quality checks were passed, and no non-conformities were found in the device's manufacturing records.The labeling contained appropriate instructions and warnings.The complaint history did not reveal an increase in similar complaints; no trend was identified.This event is filed under internal (b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE, 250 CM, Ø4.8 MM
• Common Device Name: FIBER OPTIC LIGHT CABLE, 250 CM, Ø4.8 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 23033206
• Report Number: 9610617-2025-01590
• Device Sequence Number: 9820633
• Product Code: FCW
• UDI-Device Identifier: 04048551290545
• UDI-Public: 04048551290545
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: 495NCSC
• Device Catalogue Number: 495NCSC
• Device Lot Number: SN11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 02/17/2026
• 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