MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE; FIBER OPTIC LIGHT CABLE, 250 CM, 4.8 MM

Model Number	495NCSC
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that sheath is torn - during use.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: the fiber tissue clearly shows a break / tear in the tissue.Several weaving fibers are completely severed / torn.The examination of the 495nncsc lot un46 fiber optic cable that we have shown, as described by the customer, damage to the silicone sheathing about 30 cm after the connection on the optic side.The silicone sheath is torn and folded over about 1 cm after the point of damage.The fiber tissue underneath is torn.Silicone coating torn, fiber tissue torn/broken.The damage observed indicates mechanical damage during the use of the light cable and is not due to a production/manufacturing defect.The event is filed under internal karl storz complaint id:(b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE
• Common Device Name: FIBER OPTIC LIGHT CABLE, 250 CM, 4.8 MM
• 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: 21274742
• Report Number: 9610617-2025-00093
• Device Sequence Number: 8157344
• Product Code: FCW
• UDI-Device Identifier: 04048551290545
• UDI-Public: 04048551290545
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 495NCSC
• Device Catalogue Number: 495NCSC
• Device Lot Number: UN46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/25/2025
• 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