BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1820618 · Received September 13, 2007

    Report

    Report Number
    1527736-2007-06073
    Event Type
    Malfunction
    Date Received
    September 13, 2007
    Date of Event
    July 23, 2007
    Report Date
    July 25, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE A WAS RETURNED WITH THE TISSUE PAD MISSING. AS THE TISSUE PAD WAS NOT RETURNED, FURTHER EVALUATION COULD NOT BE PERFORMED. OUR INSTRUCTION INSERT STATES: CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. THIS CAN RESULT IN POSSIBLE DAMAGE TO THE INSTRUMENT. BOTH CONDITIONS MAY CAUSE A SYSTEM FAILURE SIGNALED BY A CONTINUOUS BEEP WHEN EITHER OF THE FOOT PEDALS IS DEPRESSED AND KEEP THE CLAMP ARM OPEN WHEN BACKCUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED DURING THIS INSPECTION AND TESTING. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT THE DEVICE B WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. DUE TO THE DAMAGE TO THE BLADE, IT WAS CONFIRMED THAT THE DEVICE WAS NON-FUNCTIONAL. THE DEVICE WAS TESTED WITH A GENERATOR AND AN ERROR CODE 5 WAS NOTED. THE IDENTIFIED BLADE DAMAGE MAY HAVE OCCURRED FROM EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE. IN ADDITION, MINOR BLADE DAMAGE MAY INCREASE IN SEVERITY DURING SUBSEQUENT ACTIVATIONS, AND MAY RESULT IN BLADE "LOCKOUT" LATER IN THE PROCEDURE. FOR THIS REASON THE FOLLOWING STATEMENTS WERE INCLUDED IN THE INSTRUCTIONS FOR USE: "AVOID ACCIDENTAL CONTACT WITH ALL METAL OR PLASTIC INSTRUMENTS OR OBJECTS WHEN THE INSTRUMENT IS ACTIVATED. CONTACT WITH STAPLES, CLIPS OR OTHER INSTRUMENTS WHILE THE INSTRUMENT IS ACTIVATED MAY RESULT IN CRACKED OR BROKEN BLADES, WHICH MAY BE IDENTIFIED BY GENERATOR SOLID TONE OR INSTRUMENT ERROR." A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. RESULTS: (BLADE).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAVH THE DEVICE STOPPED WORKING AND AN ERROR CODE 5 WAS DISPLAYED. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4HA58

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR