BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3883143 · Received February 19, 2014

    Report

    Report Number
    1219930-2014-00120
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: CUSTOMER INFORMS THAT THE IDRIVE HANDLE OCCASIONALLY WHEN THE ROTATION KNOB IS ACTIVATED IT DOES NOT WORK AND ROTATES CONTINUOUSLY. THE SAME PROBLEM HAPPENS WITH THE ARTICULATION KNOB. THE ARTICULATION/ ROTATION BUTTONS WERE STICKING. THEY HAVE SOLVED THE PROBLEM WHEN THIS HAS HAPPENED REMOVING THE BATTERY AND PUTTING IT BACK AGAIN. BUT IN YESTERDAY SURGERY AFTER FIRING A 030425 SULU AND REMOVE IT THROUGH THE TROCAR, THE SULU HAS REMAINED STUCK TO THE ADAPTER AND IT HAS NOT BEEN ABLE TO UNLOAD IT. IN ORDER TO GO ON WITH THE SURGERY THEY USED ANOTHER IDRIVE SYSTEM. THERE HAS BEEN NO ISSUE WITH PT: LESS THAN 30 MINUTES DELAY, NO TISSUE LOSS OR DAMAGED, NO BLEEDING. NO REINFORCEMENT MATERIAL USED. THE SULU COULD NOT BE REMOVED FROM ADAPTER AFTER HAVING BEEN FIRED CORRECTLY AND OPEN. WHEN REMOVING THE DEVICE OUT OF THE TROCAR AND TRYING TO UNLOAD IT, THIS WAS NOT POSSIBLE. IN SOME OCCASIONS THE ROTATING CAM/KNOT REMAINS TURNED AND THE ADAPTER ROTATES EVEN WHEN RELEASING THE KNOT/CAM. THIS HAPPENS AS WELL WITH THE ARTICULATING FEATURE. WHEN THIS HAS HAPPENED ROTATING AND ARTICULATING THEY HAVE REMOVED THE BATTERY IN ORDER TO RESET THE SYSTEM AND HAD PUT IT BACK ON AGAIN AND THEN THE DEVICE HAS WORKED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103980 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N3H0806UX

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDO GIA ADAPTER STANDARD, EGIAADAPT,| MFG DATE: 08/2013| SERIAL#: (B)(4), LOT#: N3H1399UX, K121510| ENDO GIA II 45-2.5 DLU, 030425, K900129