BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 23 CM

    MDR report key: 1070656 · Received July 1, 2008

    Report

    Report Number
    3005075853-2008-00246
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 11, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE AND AFTER THE PRERUN TEST, THE HAND ACTIVATION MAX BUTTON DID NOT WORK, BUT WAS WORKING NORMALLY WITH FOOTPEDAL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 23 CM LFL ETHICON ENDO-SURGERY, LLC. NA E4KF4Z

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR