BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36CM W ERG HANDLE

    MDR report key: 1823416 · Received September 2, 2010

    Report

    Report Number
    3005075853-2010-05030
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Report Date
    August 27, 2010
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE A AND C WERE RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICES WERE TESTED WITH A GENERATOR AND BOTH WERE FUNCTIONAL. DURING INSPECTION, THE CUTTING OF THE TEST MEDIA PERFORMED AS EXPECTED. THE DEVICE (B) WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. DURING FUNCTIONAL TESTING, AN ERROR CODE 5 WAS DISPLAYED . THE DEVICE WILL STOP ACTIVATE (AND THEREFORE NOT CUT AND COAGULATE), AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. WHEN A BLADE HAS BEEN COMPROMISED SUCH AS SCRATCHED OR CRACKED, THE TITANIUM METAL IS FATIGUED WHEN CONTINUALLY ENERGIZED AND THIS RESULTS IN THE BLADE FURTHER CRACKING AND POSSIBLY BREAKING OFF. A PROBABLE CAUSE OF AN ERROR CODE 5 (INSTRUMENT ERROR) IS BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE. DEVICE A BATCH G9JL1L. MFG DATE 3-9-10. EXP DATE 2-9-15. DEVICE B BATCH F9J420. MFG DATE 12-15-09. EXP DATE 11-15-14. DEVICE C BATCH G9J88W. MFG DATE 1-22-10. EXP DATE 12-22-14.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME ADDITIONAL INFORMATION REQUESTED: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY PROCEDURE, THE SCISSORS WAS NOT COAGULATING. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36CM W ERG HANDLE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK 4RP57

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE