BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 4181380 · Received October 17, 2014

    Report

    Report Number
    1219930-2014-00959
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THE IDRIVE AND RELOAD WOULD CLOSE DOWN ON THE STOMACH BUT WOULD NOT FIRE. IT WOULD LOCK OUT. THE SURGEON COULD OPEN AND TAKE OFF THE RELOAD TO REMOVE IT FROM TISSUE. PARTIALLY FIRING BUT AS SOON AS IT HIT THE TISSUE, IT WOULD NOT FIRE. TRIED DIFFERENT RELOADS WITH SAME LOT, SAME ISSUE OCCURRED. SEPARATE CASE FROM (B)(4). THERE WAS NO UNANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT FELL INTO THE PATIENT. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660309 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRVULTRA1 N4C0611UX

    Patients

    Seq Age Sex Outcome Treatment
    1 EGIAADAPT, ENDO GIA ADAPTER STANDARD,