BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1810068 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07500
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    September 18, 2007
    Report Date
    October 24, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LAP LOW ANTERIOR PROCEDURE, AFTER RECEIVING AN ERROR CODE "INSTRUMENT" AND AFTER CLEANING, THE BLADE TIP BROKE OFF OF THE INSTRUMENT. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HM1E

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE