BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1130389 · Received August 20, 2008

    Report

    Report Number
    3005075853-2008-01311
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Report Date
    August 6, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING A GYN PROCEDURE, THE TISSUE PAD PIECE CAME OFF THE JAWS. THEY NOTICED THAT AN ABNORMAL AMOUNT OF BURNT TISSUE WAS STICKING TO THE JAWS. THEY LOOKED AROUND AND FOUND THE PIECE OF THE TISSUE PAD ON THE FLOOR. THEY SWITCHED OUT THE DEVICE FOR A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE LFL ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR