BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBER OPTIC LIGHT CABLE

    MDR report key: 14626157 · Received June 7, 2022

    Report

    Report Number
    9610617-2022-00078
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    April 26, 2022
    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 BEGINNING OF A HYSTERECTOMY PROCEDURE THE SURGEON NOTICED THE LIGHT CABLE WAS NOT ATTACHED TO THE SCOPE. THE SCOPE WAS ATTACHED AND AFTER THE PROCEDURE IN RECOVERY A NOTICEABLE "BLISTER LOOKING "MARK WAS DISCOVERED ON PATIENT'S RIGHT THIGH. BURN WAS ASSESSED BY PLASTIC SURGEON TO BE A "SUPERFICIAL BURN" AND RECOMMENDED ANTIBIOTIC OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2753183 FIBER OPTIC LIGHT CABLE LIGHT CABLE OAY KARL STORZ SE & CO. KG 495NAC 04048551290705
    655609 FIBER OPTIC LIGHT CABLE LIGHT CABLE OAY KARL STORZ SE & CO. KG 495NAC 04048551290705

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other