BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGR-O

    MDR report key: 1266289 · Received December 8, 2008

    Report

    Report Number
    1266289
    Event Type
    Malfunction
    Date Received
    December 8, 2008
    Date of Event
    November 2, 2008
    Report Date
    December 8, 2008
    Manufacturer
    ACRA CUT, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEURO PERFORATOR WOULD NOT RETRACT (NOT STOP) WHEN BEING USED BY SURGEON. THE SCRUB SAID THERE WAS SOME BLEEDING BUT WAS CONTROLLED WITH "A LITTLE EXTRA BIPOLAR AND BOVIE." THE SCRUB ALSO NOTED THAT THE PERFORATOR RETRACTED WITH CAP ON PRIOR TO USE. IT RETRACTED APPROPRIATELY PER SCRUB PRIOR TO PROCEDURE START. THE DRILL WAS SET TO A PRESSURE OF 120 PSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DGR-O CRANIAL PERFORATOR, DISPOSABLE HBF ACRA CUT, INC. 200-271 6571

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR