BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO SURGERY LLC

    MDR report key: 2440451 · Received January 31, 2012

    Report

    Report Number
    MW5024114
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 31, 2012
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE CIRCULATOR NOTED THAT THE HARMONIC GENERATOR WAS FLASHING "CLEAN TIP." THE SURGEON REMOVED THE TIP FROM THE PATIENT AND CLEANED IT. THIS KEPT REPEATING AND THE SURGEON CHANGED TO A DIFFERENT TIP. THE GENERATOR STILL SAID "CLEAN TIP" OR "TIGHTEN HANDLE." REPEATED CLEANING AND TIGHTENING PROLONGED CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO SURGERY LLC HARMONIC ACE GDW ETHICON ENDO SURGERY 43729647 STYRKER/AS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR