BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3973054 · Received March 20, 2014

    Report

    Report Number
    1219930-2014-00215
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Report Date
    February 25, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY US
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HANDLE HAS A STICKY ROTATION TOGGLE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. 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
    165443 IDRIVE ULTRA POWERED HANDLE 1 RESUABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY US N3A321UX

    Patients

    Seq Age Sex Outcome Treatment
    1