BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 2442461 · Received February 8, 2012

    Report

    Report Number
    3005075853-2012-00515
    Event Type
    Death
    Date Received
    February 8, 2012
    Date of Event
    August 22, 2011
    Report Date
    January 24, 2012
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION: THE HARMONIC DEVICES USE ULTRASONIC ENERGY TO CUT AND COAGULATE VIA VIBRATIONS IN THE BLADE; AND THE MOVEMENT OF THE BLADE HAS TO HAVE DIRECT CONTACT TO GENERATE HEAT. WE HAVE A MEDICAL OPINION FROM OUR SURGEONS ADVISING THAT THE POTENTIAL EFFECT OF INTERNAL BURNS VARIES BASED ON WHAT ORGAN OR MUCOSA IS BURNED. AS AN EXAMPLE, A BURN TO THE BOWEL IS MORE SEVERE THAN A BURN TO THE LIVER BECAUSE THE BOWEL IS CONSIDERED A "HOLLOW ORGAN" AND THE LIVER A "SOLID ORGAN." BASED ON THIS INFORMATION: HOW WAS IT DETERMINED THAT THE SHEARS BECAME HOT? WHAT IS THE LINKAGE BETWEEN THE USE OF THE ACE AND THE LIVER BEING NECROTIC? DID THE SURGEON TOUCH THE LIVER WITH THE ACE? WAS THE PATIENT BEING TREATED FOR STOMACH CANCER? ULCERS? FOR WEIGHT-LOSS? DID THE PATIENT HAVE ANY PRE-EXISTING CONDITIONS? WERE ANY OF THESE CONDITIONS RELATED TO THE LIVER? ON WHAT DATE DID THE PATIENT DIE? WAS AN AUTOPSY PERFORMED? IF YES, WHAT WAS CAUSE OF DEATH INDICATED IN REPORT? CAN WE OBTAIN A COPY OF THE AUTOPSY REPORT? IF NO AUTOPSY WAS DONE, IS THE HOSPITAL ATTRIBUTING THE PATIENT'S DEATH TO THE NSEALX22L FAILURE? IF YES, PLEASE EXPLAIN HOW THEY ARRIVE AT THIS CONCLUSION? IF NOT, WHAT OTHER PATIENT FACTORS/EVENTS LED TO THE NECROSIS OF THE LIVER? ADDITIONAL INFORMATION RECEIVED FROM INTERNATIONAL CONTACT: OUR MEDICAL AFFAIRS PHYSICIAN CAME TO THE SAME CONCLUSION THAT A DIRECT CONTACT OF A HOT INSTRUMENT WOULD NOT HAVE CAUSED SUCH A LIVER NECROSIS. THE SALES REP. INDICATED THAT THE NECROSIS MIGHT HAVE STARTED AT THE LIVER ARTERY. WE HAVE ASKED FOR THE SURGICAL REPORT AND AUTOPSY REPORT IF AVAILABLE. PLEASE FIND HERE SOME ADDITIONAL INFORMATION WE COULD OBTAIN SO FAR: FEMALE PATIENT, AGE: (B)(6). GASTRIC CARCINOMA. OPEN SURGICAL PROCEDURE. SURGEON USED HARMONIC THE FIRST TIME. SURGEON ALSO USED OTHER BIPOLAR INSTRUMENTS DURING THE PROCEDURE. ACE23E LOT. NR. G9L35V. SURGERY DATE (B)(6) 2011, PATIENT DIED FOUR DAYS AFTER THE PROCEDURE. THE SURGEON DID NOT INITIALLY COMPLAIN A HOT ACE SCISSOR OR INFORM US DIRECTLY AT THE DAY OF THE PATIENT'S DEATH. THE SALES REP GOT THIS INFORMATION DURING A VISIT AT THE HOSPITAL.

    Description of Event or Problem · 1

    RECEIVED TRANSLATED SURGERY REPORT: FEMALE PATIENT WITH SEVERE COLD (CHRONIC OBSTRUCTIVE LUNG DISEASE) GOLD III, SMOKER, EMPHYSEMA OF THE LUNG AS MEDICAL HISTORY PROCEDURE ON (B)(6) 2011: 7/8 GASTRECTOMY BECAUSE OF SMALL ANTRUM CARCINOMA; T1,N0, (ESOPHAGO)GASTROJEJUNOSTOMY PROCEDURE WITH HARMONIC AND OTHER VESSEL SEALING DEVICE; PROCEDURE ALTOGETHER WITHOUT PROBLEMS, NO MAJOR BLEEDINGS. PATIENT RECOVERED WELL, BUT AFTER THREE DAYS MURKY DRAINAGE FLUID, DETERIORATION OF GENERAL CONDITION, IN ABDOMINAL CT FREE FLUID AND NECROSES OF PANCREAS AND LEFT LIVER SEGMENTS WERE NOTED. RELAPAROTOMY ON (B)(6). THROMBOSIS OF LEFT HEPATIC ARTERY WITH NECROSIS OF LIVER SEGMENTS II AND III. NECROSES OF HEAD OF PANCREAS AND PANCREAS FRONT. NECROSIS OF BILE DUCT. EXTENSIVE IRRIGATION AND T-DRAINAGE TO BRIDGE BILE DUCT. CAREFUL REMOVAL OF NECROSES AND FIBRIN. NEVERTHELESS POSTOPERATIVELY PROGREDIENT SEPTIC SHOCK AND MULTI ORGAN FAILURE. PATIENT DIED ON (B)(6). TELEPHONIC AUTOPSY REPORT: MASSIVE EDEMA OF ALL INTERNAL ORGANS WITH FINAL FAILURE. THE OPERATING SURGEON, CLAIMS: "PROBABLY THE NEW DISSECTION TECHNIQUE HAS DAMAGED THE VESSELS MORE THAN THEORETICALLY POSSIBLE ACCORDING TO THE PERFORMANCE CHARACTERISTICS", REFERRING TO HARMONIC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A GASTRECTOMY PROCEDURE, THE SHEARS GOT HOT, LIVER GOT NECROTIC. NO FURTHER INFORMATION IS AVAILABLE. DEVICE WAS DISCARDED. THE SURGEON ALSO USED OTHER BIPOLAR INSTRUMENTS DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK G9L35V

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death GENERATOR AND HANDPIECE