BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3080707 · Received April 9, 2013

    Report

    Report Number
    1219930-2013-00235
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 14, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE DEVICE WAS TAKEN OUT OF TRAY AND WAS LOADED WITH THE BATTERY, ADAPTER, AND RELOAD. THE LIGHTS WERE NORMAL, INDICATING THREE GREEN AND THE STATUS GREEN WHEN CLOSED. THE DEVICE WAS INSERTED INTO TROCAR AND OPENED JAWS. WHILE ATTEMPTING TO POSITION, THE DEVICES JAWS WERE PARTIALLY CLOSED AND FULLY ARTICULATED TO THE RIGHT. THE SURGEON THEN WENT TO UNARTICULATE AND WAS UNABLE TO OPERATE THE DEVICE FURTHER. THE BLUE LIGHTS APPEARED. THE BATTERY WAS REMOVED AND REINSERTED. THE JAWS OPENED BUT DID NOT STRAIGHTEN. THE DEVICE HAD TO BE PULLED OUT OF THE TROCAR AND DEVICE AT THE SAME TIME. THE DEVICE WAS ABLE TO BE STRAIGHTEN AT THE BACK TABLE WITH THE ARTICULATION KNOBS; BUT, THE DEVICE WOULD NOT ARTICULATE TO LEFT. ALSO HOLDING BOTH BUTTONS WOULD NOT STRAIGHTEN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144739 IDRIVE ULTRA POWERED HANDLE 1 SURGICAL STAPLER GDW COVIDIEN, FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1