BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 652157 · Received December 12, 2005

    Report

    Report Number
    1527736-2005-06070
    Event Type
    Injury
    Date Received
    December 12, 2005
    Date of Event
    November 23, 2005
    Report Date
    December 7, 2005
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE TISSUE PAD MISSING. AS THE TISSUE PAD WAS NOT RETURNED, FURTHER EVALUATION COULD NOT BE PERFORMED. THE DEVICE WAS TESTED ON A GENERATOR, NO ERROR CODES WERE RECEIVED AND THE DEVICE ACTIVATED AND CUT PROPERLY. 510(K) # IS K042777.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC GASTRECTOMY PROCEDURE, THE SILICON TEFLON PAD OF THE INACTIVE JAW CAME OFF. THE JAW WAS CLEANED SEVERAL TIMES AND THEN LOST. UNK WHERE IT IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM ULTRACISION HARMONIC ACE LFL ETHICON ENDO SURGERY, INC. NA A9AL6M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention