BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION DISSECT HOOK 10CM

    MDR report key: 1834615 · Received December 14, 2007

    Report

    Report Number
    1527736-2007-08491
    Event Type
    Malfunction
    Date Received
    December 14, 2007
    Date of Event
    November 30, 2007
    Report Date
    December 3, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K012176
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY - INSTRUCTION INSERT ADVISES: TO AVOID USER OR PT INJURY IN THE EVENT THAT ACCIDENTAL ACTIVATION OCCURS, THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL END OF THE SHAFT SHOULD NOT BE IN CONTACT WITH THE PT, DRAPES, OR FLAMMABLE MATERIALS WHILE NOT IN USE. DURING PROLONGED ACTIVATION IN TISSUE, THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL 7 CM OF THE SHAFT MAY BECOME HOT. AVOID UNINTENDED CONTACT WITH TISSUE, DRAPES SURGICAL GOWNS, OR OTHER UNINTENDED SITES AT ALL TIMES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIAC PROCEDURE WHEN NOT IN USE THE SURGEON PLACED THE DEVICE ON THE TOP OF DRAPE NEAR THE REGION OF THE CHEST. AFTER THAT, THE SURGEON FOUND THERE WAS A HOLE ON THE DRAPE AND THE PT'S SKIN WAS BURNED ABOUT 3 MM IN DIAMETER. IT WAS NOT REQUIRED TO TREAT THE BURNED SKIN. THE SURGEON HAD BEEN PRESSING THE FOOT-SWITCH DURING THE OPERATION. BUT THE SURGEON DIDN'T HEAR THE ACTIVATION SOUNDS FROM THE GENERATOR BECAUSE OF THE LOWER THE VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION DISSECT HOOK 10CM LFL ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| FOOTSWITCH| GENERATOR