BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE POWERED HANDLE

    MDR report key: 2191830 · Received July 29, 2011

    Report

    Report Number
    1219930-2011-00642
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 15, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K102325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE RPTR: DURING THE CASE, THE TECH PLACED THE RELOAD ONTO THE HANDLE AND DID A TEST OUTSIDE THE PT CAVITY. THE RELOAD CALIBRATED CORRECTLY SURGEON THEN TOOK THE DEVICE AND PRESSED THE FIRE BUTTON BY MISTAKE. AFTER THE DEVICE WAS FIRED, THE DOCTOR PUSHED THE OPEN BUTTON AT WHICH TIME THE JAWS WOULD NOT OPEN. THE TECH THEN UNLOADED THE RELOAD WHILE IN THE CLOSED POSITION. THE TECH ATTACHED A NEW RELOAD TO HANDLE THE JAWS OF THE RELOAD AGAIN CALIBRATED CORRECTLY. THE SURGEON THEN INSERTED THE DEVICE INTO THE PELVIS, PLACED THE JAWS AT THE DISTAL END OF THE RECTUM AND THEN THE SURGEON CLOSED THE JAWS AND FIRED THE DEVICE. AFTER FIRING THE DEVICE, THE SURGEON AGAIN COULD NOT OPEN JAWS. THE SURGEON DID TRY SEVERAL TIME TO REMOVE THE UNIT WITH THE SAME OUTCOME. WITH A LIGHT WIGGLE OF THE DEVICE, THE DEVICE SEPARATED FROM THE RECTUM. THE SURGEON STATED A GOOD STAPLE LINE WAS FORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDRIVE POWERED HANDLE SURGICAL STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUFACTURE DATE: 04/2011| IDRIVE BATTERY, INTB100| IDRIVE RIGHT ANGLE LINEAR CUTTER SULU, INTRALC45| LOT NUMBER: L1D02UXR, EXP DATE: 04/30/2014