BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE¿ ULTRA REUSABLE POWERED HANDLE

    MDR report key: 6110325 · Received November 17, 2016

    Report

    Report Number
    1219930-2016-01207
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 21, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER DETAILS REGARDING PATIENT, PRODUCT OR PROCEDURE WERE PROVIDED BY THE REPORTER.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER; THE DEVICE SINGLE USE LOADING UNIT COULD NOT BE OPENED AFTER INITIALLY LOADING ONTO THE ADAPTER AND CLOSING THE UNIT WHILE TESTING PRIOR TO USE. THE RELOAD COULD ONLY BE REMOVED FROM THE DEVICE BY USING A SCREWDRIVER. THE DEVICE RELOAD WAS SUCCESSFULLY USED WITH A NEW ADAPTER AND HANDLE. THERE WAS NO PATIENT HARM OR INJURY. 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 FURTHER DETAILS REGARDING PATIENT, PRODUCT OR PROCEDURE WERE PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760261 IDRIVE¿ ULTRA REUSABLE POWERED HANDLE STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRVULTRA1 N6B0407LX

    Patients

    Seq Age Sex Outcome Treatment
    1