BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDLE AND HAND CONTROL

    MDR report key: 1112642 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01054
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K062000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING AN UNK PROCEDURE. THE TIP MELTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDLE AND HAND CONTROL LFL ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR