BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH EMAX 2 PLUS HAND PIECE - ROHS

    MDR report key: 10934689 · Received December 2, 2020

    Report

    Report Number
    3010266064-2020-02059
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    February 3, 2020
    Report Date
    December 2, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE CASE, BURR GOT STUCK IN THE ANSPACH DRILL. THE TECH WAS FINALLY ABLE TO GET THE BURR OUT OF THE DRILL BUT THE COLLAR WOULD NOT MOVE UP AND DOWN FROM THE LOCK AND UNLOCKED POSTION. NO PATIENT OR CASE IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399129 ANSPACH EMAX 2 PLUS HAND PIECE - ROHS DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1