BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1025630 · Received April 2, 2008

    Report

    Report Number
    1527736-2008-02063
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 17, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 04/02/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE BLADE BROKE OFF AND IS UNK WHERE THE BROKEN PIECE WAS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR