MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBREOPTIC LIGHT CABLE; LIGHT CABLE ASSEMBLY, 4.8 MM X 2500MM

Model Number	495NCS
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer on january 17,2025.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 the light source was left on top of the drapes and the patient was burnt on the face.

• Brand Name: FIBREOPTIC LIGHT CABLE
• Common Device Name: LIGHT CABLE ASSEMBLY, 4.8 MM X 2500MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21222373
• Report Number: 2020550-2025-00040
• Device Sequence Number: 20978338
• Product Code: FCW
• UDI-Device Identifier: 04048551001141
• UDI-Public: 04048551001141
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/22/2025
• Report Date (Section F): 01/22/2025

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: 495NCS
• Device Catalogue Number: 495NCS
• Device Lot Number: NU02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/09/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2025
• 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: Required Intervention
• Patient Sex: Unknown