BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 2043254 · Received March 31, 2011

    Report

    Report Number
    2043254
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING LAPAROSCOPIC SURGERY TO REMOVE SPLENIC CYST. CURVED SHEARS OVERHEATED, AND THE CLAMP ARM/ACTIVE BLADE BROKE AND A PORTION OF IT (APPROXIMATELY 6 MM) DROPPED INTO THE PATIENT'S ABDOMEN. IT WAS NOT RETRIEVED. THE CUT AND COAG SETTINGS ON THE ESU WERE 30. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. * H90491

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR