BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1830292 · Received August 10, 2007

    Report

    Report Number
    1527736-2007-05318
    Event Type
    Malfunction
    Date Received
    August 10, 2007
    Date of Event
    July 9, 2007
    Report Date
    July 12, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE ANALYSIS CONFIRMED THAT THE DEVICE WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND/OR MISSING. THE REMAINING BLADE PORTION HAD SCRATCHES. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR DECONTAMINATION FACILITY OR FROM OUR DECONTAMINATION TO THE ANALYSIS SITE. THE REPORTED COMPLAINT WAS ERROR CODE UNSPECIFIED. BLADE DAMAGE MAY OCCUR 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. THEREFORE, THE INSTRUCTIONAL INSERT STATES: "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. 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 INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NISSEN PROCEDURE, THERE WAS AN ERROR. 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 D4G43J

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR