BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBER OPTIC LIGHT CABLE

    MDR report key: 14576496 · Received June 2, 2022

    Report

    Report Number
    9610617-2022-00081
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    November 10, 2021
    Report Date
    September 5, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    OAY
    UDI-DI
    04048551290705
    PMA / PMN Number
    D240740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS NOT BEEN RETURNED, THEREFORE NO EVALUATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS TO CORRECT THE PRODUCT CODE FROM 'FCW' TO 'OAY'. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    AT THE START OF A HYSTERECTOMY PROCEDURE WITH DILATION AND CURETTAGE, THE LIGHT CABLE WAS NOTICED NOT TO BE CONNECTED TO THE SCOPE BUT LAID ON THE DRAPE. A BURN HOLE WAS FOUND ON THE DRAPE WHICH HAD BURNED THROUGH TO THE PATIENT'S SKIN ON RIGHT INNER THIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155027 FIBER OPTIC LIGHT CABLE LIGHT CABLE OAY KARL STORZ SE & CO. KG 495NAC 04048551290705
    2753182 FIBER OPTIC LIGHT CABLE LIGHT CABLE OAY KARL STORZ SE & CO. KG 495NAC 04048551290705

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other