BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1160626 · Received September 5, 2008

    Report

    Report Number
    3005075853-2008-01503
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 12, 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
    IL, 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 DURING A TOTAL LAP HYSTERECTOMY PROCEDURE, THE DEVICE MADE A HISSING SOUND AND THE TISSUE PAD FELL OFF THE DEVICE. NO PIECES WERE FOUND ON THE MAYO STAND AND NOT IN THE PT. THEY USED A SECOND DEVICE TO COMPLETE THE PROCEDURE. NO PT CONSEQUENCE REPORTED.

    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 GENERATOR| HANDPIECE