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	Overheating of Device (1437); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure on (b)(6) 2024, the scope that was connected to the light cable burned the patient from the hub/neck of the scope where the light cord attaches.No further information is available, other than no staff was harmed, and no delay to the procedure.
Additional Manufacturer Narrative
Customer did not confirm if they will return the device for evaluation at this time.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).A 26046bra hopkins rubina scope was used together with this device during the incident as a concomitant item (as listed in section d10), which was filed under another internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturer: according to the customer, the device was connected to the light cable at the time of the burn.The lighting was set to "automatic." the customer suffered a burn at the point where the light cable is attached to the hub/neck of the device.No employees were injured.No repairs to storz endoscopes or cables were carried out by third parties.The items listed in this report were not returned to us by the customer for detailed investigation.The instructions for use applicable to the products expressly state that the light source must be set correctly and that the correct combination of light cable and optics must be ensured in accordance with the symbols affixed.Furthermore, it is expressly stated that the optics must not be placed on the patient or flammable material or directed at the patient or flammable material.These instructions were not followed and that the patient suffered a burn.The most probable root cause is not a manufacturing/production error but an user error.This event is filed under internal complaint id (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 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 ; 4242188247
• MDR Report Key: 20328662
• Report Number: 9610617-2024-00347
• Device Sequence Number: 9574449
• Product Code: FCW
• UDI-Device Identifier: 04048551290545
• UDI-Public: 04048551290545
• Combination Product (Y/N): N
• 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): 05/29/2025

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: 495NCSC
• Device Catalogue Number: 495NCSC
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 26046BRA---HOPKINS RUBINA 30°, NIR/ICG, Ø 5 MM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown