BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2973857 · Received February 22, 2013

    Report

    Report Number
    3005075853-2013-00800
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 5, 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). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION SENT; PENDING ANSWERS. LIVER, SPLEEN AND KIDNEY HAVE LITTLE CONSEQUENCE WHEN BURNED. HOLLOW MUSCULAR ORGANS LIKE STOMACH, BLADDER AND UTERUS ARE SLIGHTLY LESS TOLERANT THAN SOLID ORGANS. AND THIN WALLED HOLLOW STRUCTURES SUCH AS SMALL BOWEL, COLON AND ESOPHAGUS ARE AT MOST RISK. WITH INTERNAL BURNS, I AM REQUIRED TO OBTAIN FOLLOW-UP FROM THE SURGEON, AS THE PATIENT RECEIVED A BOWEL BURN AND THE OUTCOME OF THE BURN MAY NOT BE IMMEDIATELY KNOWN FOR 5-7 DAYS POST-OP, COULD YOU PLEASE ADVISE: HAS THE PATIENT HAD ANY SYMPTOMS? WHAT IS THE CURRENT PATIENT CONDITION? HAS THE SURGEON BEEN IN-SERVICED ON HEAT MANAGEMENT? IS THE SURGEON AWARE OF THE WARNINGS IN THE IFU AS TO HEAT?

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND GEN04 AND IT DID ACTIVATE. DURING FUNCTIONAL TESTING, THE DEVICE WAS ACTIVATED FOR ABOUT 1 MINUTE WITH NO ABNORMAL HEAT OBSERVED. DURING AND FOLLOWING ACTIVATION IN TISSUE, THE INSTRUMENT BLADE, CLAMP ARM, AND DISTAL 7 CM OF THE SHAFT MAY BE HOT. AVOID UNINTENDED CONTACT WITH TISSUE, DRAPES, SURGICAL GOWNS, AT ALL TIMES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, IT WAS FOUND THAT WHITE THERMAL DAMAGE (ABOUT 1CM IN LENGTH) ON THE SMALL BOWEL THOUGH THE CLAMP ARM TOUCHED THE SMALL BOWEL FOR A SHORT TIME WHEN THE DEVICE WAS USED FOR ABRASION OF THE FAT ON THE ABDOMINAL WALL. THERE WAS NO SMALL-BOWEL PERFORATION AND A SUTURE FOR THE THERMAL DAMAGE WAS PERFORMED TO COMPLETE THE CASE VIA ALREADY SET SMALL INCISION FOR AN ANASTOMOSIS WITHOUT CONVERTING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO THERMAL DAMAGE ON THE SURGEON. ONE DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78050 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK J90W7R

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE