BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1112636 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01038
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 21, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT THE DEVICE WAS RETURNED WITH THE TISSUE PAD MISSING ON THE ASSEMBLY (PIECE WAS RETURNED). THE BATCH RECORD WAS REVIEWED, AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE THE TISSUE PAD FELL OFF OF THE DEVICE. NO PIECE FELL INTO THE PT. IT IS NOT KNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO-SURGERY, LLC NA E4KN10

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE