BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 1833435 · Received September 14, 2010

    Report

    Report Number
    3005075853-2010-05258
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 20, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDED ADDITIONAL INFORMATION THE DEVICE WAS RECEIVED WITH THE BLADE DISCOLORED (BLUE) DUE TO HEAT GENERATED FROM CONTACT BETWEEN THE BLADE AND TISSUE PAD. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. THE BLADE WAS FOUND TO BE BROKEN AT THE DISCOLORED (BLUE). PROBABLE CAUSE OF BLADE DISCOLORATION IS APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TITANIUM TIP OF THE SCALPEL WAS BROKEN. THE BROKEN PART DID NOT FALL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 7.0 INR ON THE COAGUCHEK XS SYSTEM WHILE A COMPARISON LAB RETURNED AS 4.5 INR. PATIENT WAS TREATED WITH AN ORAL DOSE OF VITAMIN K BASED ON METER RESULT. PATIENT'S COUMADIN DOSE WAS ALSO HELD FOR ONE DAY. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK G4T67P

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE