BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBER OPTIC LIGHT CABLE

    MDR report key: 17290743 · Received July 10, 2023

    Report

    Report Number
    9610617-2023-00657
    Event Type
    Injury
    Date Received
    July 10, 2023
    Report Date
    June 16, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    FCW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0074 CORRECTIVE ACTION 6. INVESTIGATION REVEALED THAT THE LIGHT CABLE DOES NOT SHOW ANY DEFECTS. THE FACT THAT LIGHT CABLES BECOME HOT IS STATED IN THE INSTRUCTIONS FOR USE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID ((B)(4)).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS EVENT WITH A LIGHT CABLE. ACCORDING TO THE INFORMATION RECEIVED, A NURSE BURNED HERSELF ON A LIGHT CABLE IN THE OPERATING ROOM DURING PROCEDURE. THE DEGREE OF BURN IS NOT KNOWN. FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693485 FIBER OPTIC LIGHT CABLE FIBREOPTIC LIGHT CABLE FCW KARL STORZ SE & CO. KG 495ND XR39

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other