BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2091686 · Received May 17, 2011

    Report

    Report Number
    3005075853-2011-02006
    Event Type
    Death
    Date Received
    May 17, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 5/17/2011. INFORMATION ASKED FOR, BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 DAYS POST-OP OF A LAP ANTERIOR RESECT FOR DIVERTICULAR DISEASE PROCEDURE, THE PATIENT DIED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CAUSE FOR CONCERN. NO OTHER ENERGY WAS USED LAPAROSCOPICALLY. EC60A WAS USED FOR RESECTION AND CDH29A FOR ANASTAMOSES. TWO DAYS POST OPERATIVELY THE PATIENT BECAME ILL/SEPTIC. IT WAS DETERMINED THAT THE PATIENT HAD A LEAK. THE PATIENT WAS RETURNED TO THEATRE ON (B)(6) 2011 WHERE IT WAS DETERMINED SHE HAD A SMALL BOWEL PERFORATION THAT WAS ATTRIBUTED TO HARMONIC. THE SURGEON STATED THAT THERE WAS EVIDENCE OF A HARMONIC BURN ON THE SMALL BOWEL WHERE THE LEAK ORIGINATED FROM. THE SURGICAL TEAM PERFORMED A SMALL BOWEL RESECTION AND THE PATIENT WAS IN INTENSIVE CARE UNIT. THE PATIENT REQUIRED FURTHER SURGERY ON (B)(6) 2011 - THE REST OF THE PATIENT'S LARGE BOWEL WAS REMOVED AS WAS ANOTHER SECTION OF SMALL BOWEL. SURGEON STATED THAT UPON OPENING ON THE THIRD PROCEDURE IT WAS DISCOVERED THAT THE LARGE BOWEL WAS ISCHEMIC AND NECROTIC AS WAS THE MAJORITY OF THE SMALL BOWEL. (B)(6) 2011; THE TEAM COMMENTED THAT THE PATIENT IS IN CRITICAL CONDITION AND HER PROGNOSIS WAS VERY POOR. (B)(6) 2011 (NIGHT); THE PATIENT DIED. ONE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION: SURGEON STATED SHE IS VERY AWARE OF THE HEAT PRODUCED IN THE BLADE OF THE HARMONIC DEVICE AND IS ALWAYS CAUTIOUS OF NOT USING THE HARMONIC AS A GRASPER AND TO AVOID IT CONTACTING NON RESECTABLE STRUCTURES. SHE STATED THAT THE BURN MAY HAVE OCCURRED WHEN THE TIP OF THE HARMONIC WAS OUT OF VIEW - SUCH AS DURING INSERTION OR REMOVAL OF THE DEVICE THROUGH A TROCAR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE CAUSE OF DEATH AS WRITTEN ON THE DEATH CERTIFICATE WAS: OVERWHELMING SEPSIS SECONDARY TO SMALL BOWEL LEAK.

    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 67 YR Death GENERATOR AND HANDPIECE