BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMAX-PLUS MOTOR ASSY

    MDR report key: 2961156 · Received January 30, 2013

    Report

    Report Number
    1045834-2013-00160
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    K965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE "STOPPED WORKING" IN AN EAR SURGERY. THE REPORTER STATED THAT "THEY TRIED CHANGING ATTACHMENTS ON THE DRILL, BUT THE BURR WOULD NOT SPIN." THE REPORTER ALSO STATED THAT THE COUPLING WAS "STIFF" ON THE DRILL. IT WAS ALSO REPORTED THAT THERE WAS A 15 MINUTE DELAY IN SURGERY TO BORROW A DRILL FROM ANOTHER OPERATING ROOM. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40720 MICROMAX-PLUS MOTOR ASSY ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR