BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA, SURGICAL AND ACCESSORIES, PRODUCT CODE: KQM, PRODUCT CODE: KQM

    MDR report key: 18955944 · Received March 21, 2024

    Report

    Report Number
    3006437518-2024-00008
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    January 22, 2024
    Report Date
    March 15, 2024
    Manufacturer
    DKK DAI-ICHI SHOMEI CO., LTD.
    Product Code
    KQM
    PMA / PMN Number
    K071698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AUR7 LIGHT HEAD WAS FOUND HANGING OFF THE INTERNAL BANDS THAT KEEP THE LIGHT HEAD ATTACHED TO THE YOKE. THERE IS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318122 CAMERA, SURGICAL AND ACCESSORIES, PRODUCT CODE: KQM, PRODUCT CODE: KQM KQM DKK DAI-ICHI SHOMEI CO., LTD. AUR7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown