BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2133643 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02487
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    January 12, 2011
    Report Date
    May 27, 2011
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE BEING HELD BY RISK MANAGEMENT. IFU STATES, UNDER "WARNINGS." "AVOID CONTACT WITH ANY AND 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." REGARDING THE BLADE CRACKING OR BREAKING, THIS IS THE RESULT OF THE BLADE BEING DAMAGED DURING THE COURSE OF THE SURGICAL PROCEDURE DUE TO CONTACT WITH OTHER METAL INSTRUMENTS. WHEN THIS OCCURS, THE SYSTEM GIVES AN ERROR CODE OR SOLID TONE, ADVISING OF A POSSIBLE INSTRUMENT PROBLEM, AND THAT TROUBLESHOOTING STEPS MUST BE FOLLOWED. THESE STEPS ARE: ERROR: INSTRUMENT FAILURE: TIGHTEN INSTRUMENT USING BLADE WRENCH AND CAREFULLY REMOVE ANY TISSUE WHICH MAY BE LODGED INSIDE THE DISTAL END OF THE INSTRUMENT SHEATH. PRESS STANDBY TO CLEAR ERROR AND RETURN TO READY MODE. ACTIVATE SYSTEM. IF THE PRE-RUN TEST IS RUNNING, ENSURE INSTRUMENT IS IN THE AIR. IF USING SHEARS, ENSURE THAT JAWS ARE OPEN AND NOT IN CONTACT WITH ANY OBJECT DURING PRE-RUN TEST. IF ERROR PERSISTS, INSTALL A TEST TIP PRESS TEST BUTTON. IF HAND PIECE ERROR OCCURS, REPLACE HAND PIECE OR INSTALL NEW TEST TIP AND PRESS TEST. IF NO ERROR OCCURS, REPLACE INSTRUMENT. PRESS STANDBY TO RETURN TO READY MODE. ACTIVATE SYSTEM. WHEN THESE STEPS ARE NOT FOLLOWED, AND THE SURGEON CONTINUES TO USE THE BLADE, (WHICH MAY BE CRACKED DUE TO DAMAGE, THE CRACK CAN PROPAGATE AND RESULT IN A BROKEN BLADE.

    Description of Event or Problem · 1

    PER USER FACILITY MEDWATCH FORM (B)(4), DURING A LAPAROSCOPICALLY ASSISTED SUPRACERVICAL HYSTERECTOMY PROCEDURE, THE ROOM CIRCULATOR RETURNING FROM LUNCH WAS NOTIFIED BY RELIEVING CIRCULATOR THAT A PIECE OF THE HARMONIC SCALPEL HAD BROKEN OFF AND WAS STILL IN THE PATIENT'S BODY. THE BLADE TIP WAS FOUND VIA X-RAY AND REMOVED LAPAROSCOPICALLY. OPERATOR OF THE EQUIPMENT APPLIED THE TIP OF THE SCALPEL AGAINST ANOTHER METAL INSTRUMENT CAUSING SIGNIFICANT VIBRATION OF THE SCALPEL. EQUIPMENT ALARMED SEVERAL TIMES. TIP BROKE OFF AFTER MULTIPLE CLEANING ATTEMPTS AND CONTINUED USE DURING THE PROCEDURE. THE DEVICE IS CURRENTLY WITH RISK MANAGEMENT. IT WILL NOT BE AVAILABLE FOR RETURN UNTIL IT HAS BEEN CLEARED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR GENERATOR AND HANDPIECE