BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1162327 · Received September 8, 2008

    Report

    Report Number
    3005075853-2008-01578
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 09/08/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP BOWEL PROCEDURE, THE SURGEON FELT THE TIP OF THE BLADE WAS GETTING HOTTER THAN NORMAL. THEY CONTINUED TO USE THE INSTRUMENT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE