BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1820184 · Received October 30, 2007

    Report

    Report Number
    1527736-2007-07163
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Report Date
    September 7, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT DEVICES A AND B WERE RETURNED WITH EVIDENCE OF B-FORM STAPLES EMBEDDED IN THE TISSUE PAD AND WITH THE BLADES SCRATCHED AND CRACKED. DUE TO THE DAMAGE TO THE BLADES, IT WAS CONFIRMED THAT THE DEVICES WERE NON-FUNCTIONAL. THE DEVICES WERE 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." EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT, AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED AT THIS PROCESS. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE STOPPED WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HM45

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE