BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 4243418 · Received November 11, 2014

    Report

    Report Number
    1219930-2014-01044
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 20, 2014
    Report Date
    November 2, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: WEDGE RESECTION. ACCORDING TO THE REPORTER: LAPAROSCOPIC WEDGE RESECTION: INTRA-OPERATIVELY, THE DOCTOR HAD THE IDRIVE IN HIS HANDS. WITHOUT ADDITIONAL MANIPULATION, THE ADAPTER MADE A CYCLING NOISE, WITH THE RELOAD STILL ATTACHED TO THE ADAPTER. THE RELOAD UNCONTROLLABLY ARTICULATED. BLUE STATUS LIGHT CAME ON. RELOAD REMOVED AND REATTACHED, WHICH INITIALLY FIXED THE PROBLEM, BUT THEN THE ISSUE PROCEEDED TO HAPPEN TWO MORE TIMES. EVENTUALLY A DISPOSABLE HANDLE WAS OPENED (THE EGIAUXL) AND THIS COMPLETED THE CASE WITH NO FURTHER ISSUES. THERE WERE NO ADVERSE OUTCOMES FOR THE PATIENT REPORTED. NO REINFORCEMENT MATERIAL WAS USED. THERE WAS NO UNANTICIPATED TISSUE LOSS, NO TISSUE DAMAGE, NO BLOOD LOSS OF 500CC OR MORE, AND NO EXTENSION TO SURGICAL TIME BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725697 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRVULTRA1 N3G0575UX

    Patients

    Seq Age Sex Outcome Treatment
    1 PRODUCT NUMBER: EGIAADAPT,