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	01/08/2025
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.
Additional Manufacturer Narrative
Investigation: in the corresponding ifu fiber optic light cable, fluid light cables dsx551_en_v2.1_08-2024_ifu_ce-mdr, karl storz make clear reference to this under points 3.3 hot components and 3.4 high light intensity.On the optics-side connection, a melted adhesion (plastic) is visible on the front of the optical fibers which presumably originates from cover cloth contact.At the device-side connection, individual optical fibers are broken on the surface in certain areas of the device broken optical fiber are visible.This damage is due to normal use and the age of the light cable (january 2015) and was not caused by a manufacturing or production defect.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• 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: 21222398
• Report Number: 9610617-2025-00040
• Device Sequence Number: 3326158
• 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: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 04/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown