BEUDAMED
    FDA Adverse Event Other Summary report: N

    DORO 3-PT HFD

    MDR report key: 2115388 · Received May 24, 2011

    Report

    Report Number
    3003923579-2011-00002
    Event Type
    Other
    Date Received
    May 24, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 15, 2011
    Manufacturer
    PRO MED INSTRUMENTS, GMBH
    Product Code
    HBL
    PMA / PMN Number
    K063494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED BY MANUFACTURER AND ALLEGED FAILURE COULD NOT BE DUPLICATED. COMPETE INSPECTION WAS PERFORMED. SUSPECT THAT THE INDEX KNOB WAS NOT PROPERLY LOCKED. WE REVIEWED OUR INSTRUCTION MANUAL AND DECIDED THERE ARE NO CHANGES/ADDITIONS REQUIRED. WE REFERRED THE USER TO THE INSTRUCTION MANUAL, SECTION 6, INCLUDING ALL WARNING STATEMENTS AND SAFETY INFORMATION, ADDITIONAL TRAINING TO STAFF AT HOSPITAL IS PLANNED.

    Description of Event or Problem · 1

    CRANI FOR TUMOR. PT IN THE PRONE POSITION. THE PT WAS SUPINE AND THEN POSITIONED PRONE, PREPPED AND DRAPED. DURING THE BEGINNING OF THE PROCEDURE THE PHYSICIAN THOUGHT THE HEAD SLIPPED A LITTLE AND THEN THE STEALTH WAS NOT WORKING ACCURATELY BUT CONTINUED WITH THE PROCEDURE. AT THE END OF THE CASE AFTER THE DRAPES WERE REMOVED AND THE PT WAS POSITIONED SUPINE AGAIN TO REMOVE 3-POINT FIXATION HEADHOLDER, A SMALL APPROX 2CM LACERATION WAS FOUND AND THAT WAS CLOSED WITH STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORO 3-PT HFD NEUROSURGICAL HEAD HOLDER (SKULL CLAMP) HBL PRO MED INSTRUMENTS, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other