BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRW PRECISION ARC SYSTEM

    MDR report key: 2573054 · Received May 9, 2012

    Report

    Report Number
    1222895-2012-00011
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 9, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    PMA / PMN Number
    K944463
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A CRW ARC PRECISION SYSTEM WAS BEING USED FOR STEREOTACTIC BRAIN BIOPSY WHEN FRAME SLIPPED ON THE PTS' HEAD JUST AS THE PHYSICIAN WAS GOING TO DO THE BIOPSY. ORIGINALLY THE EVENT WAS DESCRIBED AS: "THE UNIT SLIPPED FROM THE PTS' HEAD". HOWEVER, THE UNIT DID NOT SLIP FROM THE PTS' HEAD RATHER THE SURGEON FELT THAT THE FRAME "SLIPPED" WHEN HE WENT TO TAKE THE BIOPSY AND THE BIOPSY, THEREFORE, WENT 2MM DEEPER THAN INTENDED. THE FRAME "SLIPPED" SHORTLY AFTER STARTING THE BIOPSY PROCEDURE, JUST A FEW MINUTES INTO THE CASE. THE PT WAS NOT "REPOSITIONED" PRIOR TO THIS EVENT BUT, RATHER HE WAS POSITIONED FOR THE PROCEDURE. THERE WAS ABOUT A 10 MINUTE DELAY IN THE CASE AS THE PHYSICIAN ATTEMPTED TO RE-SECURE THE DEVICE. HE WAS ABLE TO DO SO AND COMPLETED THE CASE WITHOUT INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRW PRECISION ARC SYSTEM STEREOTAXY HAW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR