BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOLLORF? XL90, ASPIRATING ABLATOR 90°

    MDR report key: 8865863 · Received August 6, 2019

    Report

    Report Number
    1220246-2019-01235
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 18, 2019
    Report Date
    November 5, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    GEI
    UDI-DI
    00888867267220
    PMA / PMN Number
    K161581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED, THE CERAMIC COMPONENT WAS FOUND TO BE CHIPPED. DAMAGE AND DENTING WAS OBSERVED ON THE ELECTRODE AT EACH CHIP LOCATION. LIKELY CAUSES OF THE EVENT INCLUDE HITTING ANOTHER OBJECT AND/OR USER-APPLIED MECHANICAL FORCES.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, THE AR-9821, LOT: 1811132 WAS USED. WHEN X-RAY WERE TAKEN AFTER THE SURGERY, A SMALL METAL FRAGMENTS WERE IDENTIFIED IN THE PATIENT'S BODY. ALL EQUIPMENT USED IN THE SURGERY WERE CONFIRMED BUT NO DAMAGE WAS FOUND. THERE IS NO PLAN FOR REVISION SURGERY BECAUSE THE BROKEN PIECES ARE VERY SMALL AND IT WAS REPORTED IT WILL NOT LEAD TO SERIOUS DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659702 APOLLORF? XL90, ASPIRATING ABLATOR 90° ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHREX, INC. APOLLORF? XL90, ASPIRATING ABLATOR 90° 1811132 00888867267220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other