BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3113546 · Received May 15, 2013

    Report

    Report Number
    3005075853-2013-02340
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 1, 2013
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE A WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND NOT RETURNED. THE REMAINING BLADE PORTION WAS SCRATCHED. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE. THE REPORTED COMPLAINT WAS FOR AN ERROR 5 WAS DISPLAYED DURING USE. THE DEVICE WAS ACTIVATED WITH THE GENERATOR AND AN ERROR CODE 5 WAS DISPLAYED. IN ADDITION, MINOR BLADE DAMAGE MAY INCREASE IN SEVERITY DURING SUBSEQUENT ACTIVATIONS, AND MAY RESULT IN BLADE "LOCKOUT" LATER IN THE PROCEDURE. WHEN A BLADE IS DAMAGED, IT MAY NOT COMPLETE THE PRE-RUN TESTING, WILL DISPLAY AN ERROR CODE AND WILL KEEP REVERTING BACK TO STANDBY MODE. 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. IF THE HARMONIC SYSTEM SENSES AN INSTRUMENT FAULT DURING USE, AN AUDIBLE ALARM (TONE WITH LONG PULSES) WILL SOUND AND A VISUAL ALARM INDICATOR WILL APPEAR ON THE CONTROL PANEL. THE GENERATOR SYSTEM WILL REVERT TO STANDBY MODE, WHEN THE AUDIBLE ALARM (SOLID TONE) AND VISUAL ALARM INDICATOR APPEAR. DEVICE B WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS TESTED WITH A GENERATOR AND WAS FUNCTIONAL, IN ADDITION, THE DEVICE ACTIVATED WITH BOTH MAX AND MIN BUTTONS. THE TISSUE PAD OF THE DEVICE WAS IN GOOD PHYSICAL CONDITION. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. IT COULD NOT BE DETERMINED WHY REPORTEDLY AN ERROR 5 WAS DISPLAYED DURING USE. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. DEVICE B: BATCH J92Z8J, MFG DATE 12/1/2012, EXP DATE 11/12/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AN ERROR 5 WAS DISPLAYED DURING USE. THE 2ND DEVICE WAS USED, BUT THE SAME EVENT OCCURRED. THE 3RD DEVICE AND ANOTHER HAND PIECE WERE USED, THE 3RD DEVICE WAS ACTIVATED. THE 3RD DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE BLADE OF THE 1ST DEVICE WAS BROKEN OFF WHEN A CLINICAL ENGINEER CHECKED IT AFTER OPERATION. NO PIECES FELL INTO THE PATIENT. TWO DEVICES WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214304 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J92Z8D

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE