BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1100283 · Received August 5, 2008

    Report

    Report Number
    3005075853-2008-00911
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 11, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TISSUE PAD MELTED DURING THE LAP SPLENECTOMY. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE CASE WITH NO PT 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