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

Model Number	495NCSC
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
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).
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.

• 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
• MDR Report Key: 20328581
• Report Number: 2020550-2023-00347
• Device Sequence Number: 15860102
• Product Code: FCW
• UDI-Device Identifier: 04048551290545
• UDI-Public: 04048551290545
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2024
• Report Date (Section F): 09/27/2024

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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