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	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury

• 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,
• MDR Report Key: 50809831
• Report Number: 2020550-2026-02195
• Device Sequence Number: 10589930
• Product Code: FCW
• UDI-Device Identifier: 04048551290545
• UDI-Public: 04048551290545
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026
• Report Date (Section F): 09/17/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown