BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2854946 · Received December 3, 2012

    Report

    Report Number
    3005075853-2012-05436
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. ADDITIONAL INFORMATION: DID THE TITANIUM BLADE TIP FALL INTO THE PATIENT? YES. WAS THE TIP LEFT INSIDE THE PATIENT? NO. OR WAS THE BLADE TIP RETRIEVED? YES, THE TIP WAS RETRIEVED AND WILL BE SENT IN WITH THE DEVICE. HOW WAS THE TIP RETRIEVED? (E.G. CONVERT TO OPEN?; REMOVED THROUGH TROCAR?) DESCRIBE HOW. REMOVED THROUGH TROCAR. WAS THERE A SOLID TONE PRIOR TO NOTICING THE BROKEN BLADE TIP? ACCORDING TO THE SURGEON, NO TONE WAS HEARD PRIOR TO THE BROKEN BLADE. WAS THERE AN ERROR CODE PRODUCED PRIOR TO NOTICING THE BROKEN BLADE TIP? THE STAFF NOTICED A "RELAX PRESSURE ON TISSUE" ERROR ONCE. WHICH ERROR CODE? SEE ABOVE. WAS THERE ANY CONTACT WITH METAL DURING ACTIVATION OF THE DEVICE? NO. WERE THERE ANY TRANSACTIONS ACROSS STAPLE LINES? NO. WERE THE TROUBLESHOOTING TECHNIQUES FOLLOWED WHEN THE ERROR CODE/SOLID TONE WAS RECEIVED? HOW WAS PROCEDURE COMPLETED? DESCRIBE HOW. THE ERROR WAS NOTICED AND BY PRESSING THE ACTIVATION BUTTON THE PROCEDURE CONTINUED. THE PROCEDURE WAS COMPLETED WITH THE SECOND INSTRUMENT WITHOUT ANY PROBLEMS OR NEGATIVE OUTCOMES FOR THE PATIENT. THE DEVICE WAS RECEIVED WITH THE BLADE BROKEN OFF AND PRESENT. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN11 INSTRUMENT ERROR SCREEN WAS RECEIVED AND WHEN TESTED WITH GEN04 AN ERROR CODE 5 WAS DISPLAYED. 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 LOCATION OF THE BREAK IS INSIDE THE TUBE PROXIMAL TO THE TISSUE PAD. THE ANALYSIS CONCLUDED THAT THE BLADE BROKE OFF DUE TO CONTACT WITH THE INNER TUBE. THIS DAMAGE WAS MOST LIKELY DUE TO EXCESSIVE SIDE FORCES APPLIED TO THE BLADE WHILE ACTIVATING RESULTING IN BLADE CONTACT WITH THE INNER TUBE. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE ACTIVE JAW OF THE INSTRUMENT FELL OFF WHILE CREATING THE COLPOTOMY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE