BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT SWIVEL COLLIMATOR

    MDR report key: 854510 · Received May 22, 2007

    Report

    Report Number
    1450503-2007-00001
    Event Type
    Malfunction
    Date Received
    May 22, 2007
    Date of Event
    May 15, 2007
    Report Date
    May 22, 2007
    Manufacturer
    SUMMIT INDUSTRIES, INC.
    Product Code
    KPW
    PMA / PMN Number
    K874687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMIT INDUSTRIES HAS NOT YET RECEIVED THE SUBJECT UNIT FOR EVALUATION. THE SUMMIT DEALER WAS NOTIFIED OF THE INCIDENT AND WENT TO THE USER FACILITY (UF) WHERE HE DETERMINED THAT THE COLLIMATOR SWIVEL RETAINING SCREWS HAD BECOME LOOSE AND/OR WERE MISSING WHEN THE COLLIMATOR FELL. ONE OR MORE OF THE REMAINING SCREWS HAD POSSIBLY PULLED OUT OF THE SWIVEL MOUNT ASSEMBLY, STRIPPING THE LAST TWO OF THE 8 THREADS IN THE MOUNTING ASSEMBLY. TO KEEP THE CLINIC OPERATING, HE DETERMINED THAT REPLACING THE ORIGINAL 1/4" RETAINING SCREWS WITH 1/2" ONES THAT FULLY ENGAGE THE REMAINING 6 THREADS AND ADDING LOCK-TIGHT WOULD BE ADEQUATE UNTIL A REPLACEMENT UNIT COULD ARRIVE FROM THE MFR, SUMMIT INDUSTRIES. AT THAT TIME, THE SUBJECT UNIT WILL BE RETURNED TO SUMMIT INDUSTRIES FOR EVALUATION.

    Description of Event or Problem · 1

    SUMMIT SWIVEL COLLIMATOR MODEL # D800 CAME FREE FROM THE TUBEMOUNT, LANDING ON THE TABLE TOP, BUMPING THE HAND OF A PT. THE PT WAS RECEIVING FOLLOW UP CARE AFTER WRIST SURGERY. SUBSEQUENT X-RAYS INDICATED THAT THE SURGICAL WORK WAS UNAFFECTED BY THE INCIDENT AND THAT NO ADD'L INJURY RESULTED. THE FAILURE APPEARS TO HAVE RESULTED FROM LOOSE OR MISSING HARDWARE ON THE SWIVEL ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT SWIVEL COLLIMATOR BEAM LIMITING DEVICE KPW SUMMIT INDUSTRIES, INC. D800 ND513-1298

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other