MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LIGHT CABLE ASSEMBLY, 4.8 MM X 3000MM

Model Number	495NE
Medical Device Problem Codes	Material Erosion (1214); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, cable was getting too hot and consequently end melted.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: during the technical inspection, the error description provided by the customer, "cable was getting too hot and consequently end melted", was not confirmed.During the examination of the optical cable in question, normal signs of wear and tear, such as impact marks, deformations, and individual broken optical fibers, were found at the respective connection ends for the age of the optical cable (year of manufacture 2016).Regarding the customer's information (cable was getting too hot and consequently end melted), no temperature-related damage could be detected.The edges of the respective connection ends are deformed or show impact marks.The damage found was caused by clinical use/clinical reprocessing and cannot be attributed to a production/manufacturing defect.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: LIGHT CABLE ASSEMBLY, 4.8 MM X 3000MM
• Common Device Name: LIGHT CABLE ASSEMBLY, 4.8 MM X 3000MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 23632907
• Report Number: 1221826-2025-02137
• Device Sequence Number: 10314879
• Product Code: FCW
• UDI-Device Identifier: 04048551168905
• UDI-Public: 04048551168905
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 495NE
• Device Catalogue Number: 495NE
• Device Lot Number: TT17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/27/2026
• 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: Required Intervention
• Patient Sex: Unknown