BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 HARMONIC SCAPEL

    MDR report key: 1011163 · Received February 15, 2008

    Report

    Report Number
    1011163
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 8, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ETHICON ENDO- SURGERY INC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, THE DISPOSABLE HARMONIC SHEARS STOPPED CUTTING. THE SHEARS WERE RINSED AND RETESTED. NOT CUTTING. THE CORD WAS TESTED - NO FAILURE DETECTED. THE GENERATOR WAS WORKING FINE. THE SHEARS WERE REPLACED WITH NEW ONES, AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 HARMONIC SCAPEL SHEARS, HARMONIC LFL ETHICON ENDO- SURGERY INC * D4JV05

    Patients

    Seq Age Sex Outcome Treatment
    1 *