BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAL ACCESS ATTACHMENT

    MDR report key: 3042881 · Received April 4, 2013

    Report

    Report Number
    1045834-2013-01360
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 12, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K042783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE EVENT WAS DUPLICATED. EVIDENCE INDICATES THIS WAS DUE TO USAGE WEAR OVER TIME. THE EVENT WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "UNABLE TO HOLD THE BURR," DISCOVERED BEFORE THE PROCEDURE. THERE WAS A MINOR DELAY IN THE START OF THE PROCEDURE, NO SPECIFIC TIME AVAILABLE. A SPARE ATTACHMENT WAS AVAILABLE FOR USE. THE DEVICE WAS NOT USED IN SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139075 MINIMAL ACCESS ATTACHMENT HBE THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1