BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARMONIC ACE + 7

    MDR report key: 6137649 · Received December 1, 2016

    Report

    Report Number
    3005075853-2016-06734
    Event Type
    Death
    Date Received
    December 1, 2016
    Report Date
    November 17, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K132612
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DATE SENT: 12/1/2016. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT WERE THE INDICATIONS FOR SURGERY? WAS A DRAIN PLACED DURING THE INITIAL SURGERY? WHERE WAS THE DEVICE USED IN THE PROCEDURE? WHAT VESSELS AND STRUCTURES WERE USED BY THE HARH36? WHAT WAS THE HEMOGLOBIN TREND? WHERE THERE OTHER DEVICES USED IN THE PROCEDURE TO ACHIEVE HEMOSTASIS? WHERE THERE ANY ISSUES WITH HEMOSTASIS DURING THE INITIAL SURGERY? WAS THE SITE OF THE BLEED IDENTIFIED POST-OPERATIVELY? WAS ANY LIFE SAVING MEASURES TAKEN? WAS AN AUTOPSY PERFORMED? IF YES, IS THE REPORT AVAILABLE? WAS THE PATIENT IN THE HOSPITAL AT THE TIME OF EXPIRATION? IS THE SURGEON WILLING TO SPEAK WITH MEDICAL PERSONNEL? WERE THERE ANY ERROR MESSAGES? IF YES, WHICH ONES? WHAT WAS THE NATURE OF THE DAMAGE TO THE ARTERY?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WERE THE INDICATIONS FOR SURGERY?---NO INFORMATION. WAS A DRAIN PLACED DURING THE INITIAL SURGERY? --- YES. WHERE WAS THE DEVICE USED IN THE PROCEDURE? --- NO INFORMATION. WHAT VESSELS AND STRUCTURES WERE USED BY THE HARH36? --- SHORT GASTRIC ARTERIES AND LIENAL ARTERY. THE PROXIMAL END OF THE VESSELS WAS CLIPPED AND THEN CUT BY THE HARH36 ON THE ADVANCED HEMOSTASIS MODE. WHAT WAS THE HEMOGLOBIN TREND? --- NO INFORMATION. CRP LEVEL AND AMYLASE LEVEL WERE NORMAL TILL THE DAY BEFORE THE PATIENT WAS DEAD. WHERE THERE OTHER DEVICES USED IN THE PROCEDURE TO ACHIEVE HEMOSTASIS? --- NO INFORMATION. WHERE THERE ANY ISSUES WITH HEMOSTASIS DURING THE INITIAL SURGERY? ---NO INFORMATION. WAS THE SITE OF THE BLEED IDENTIFIED POST-OPERATIVELY? --- NO INFORMATION. WAS ANY LIFE SAVING MEASURES TAKEN? ---NO INFORMATION. WAS AN AUTOPSY PERFORMED? IF YES, IS THE REPORT AVAILABLE? ---YES. BUT THE REPORT IS NOT AVAILABLE. THE BLEEDING MIGHT OCCURRED FROM SHORT GASTRIC ARTERIES OR LIENAL ARTERY. WAS THE PATIENT IN THE HOSPITAL AT THE TIME OF EXPIRATION? ---NO INFORMATION. IS THE SURGEON WILLING TO SPEAK WITH MEDICAL PERSONNEL? ---NO INFORMATION. WERE THERE ANY ERROR MESSAGES? IF YES, WHICH ---NO. THE DOCTOR THOUGHT THIS DEVICE WAS NOT CAUSE OF BLEEDING. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: THE DEVICE WAS USED ON THE SHORT GASTRIC ARTERIES AND LIENAL ARTERY. THE INFORMATION PROVIDED STATES: ¿THE BLEEDING MIGHT OCCURRED FROM SHORT GASTRIC ARTERIES OR LIENAL ARTERY.¿ WHAT DEVICE DOES THE SURGEON THINK CAUSED THE BLEEDING? WHAT OTHER DEVICES WERE USED? AS THE INFORMATION ADVISED: THE DOCTOR THOUGHT THIS DEVICE WAS NOT CAUSE OF BLEEDING, WHAT DOES THE DOCTOR BELIEVED CAUSED THE BLEEDING?

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON ADDITIONAL INFORMATION RECEIVED (BELOW) THE EVENT NO LONGER MEETS THE CRITERIA OF A REPORTABLE EVENT. ADDITIONAL INFORMATION RECEIVED: WHAT DEVICE DOES THE SURGEON THINK CAUSED THE BLEEDING. THE SURGEON THOUGHT THE CAUSE OF BLEEDING WAS NOT THE DEVICE. WHAT OTHER DEVICES WERE USED? NO INFORMATION WAS GET FROM THE SURGEON. AS THE INFORMATION ADVISED: THE DOCTOR THOUGHT THIS DEVICE WAS NOT CAUSE OF BLEEDING, WHAT DOES THE DOCTOR BELIEVED CAUSED THE BLEEDING? OUR SALES REP TRIED TO GET THE INFORMATION BUT DIDN¿T GET THE OTHER INFORMATION THAN IT REGARDING THE CAUSE OF BLEEDING FROM THE SURGEON. IS THE SURGEON WILLING TO SPEAK WITH MEDICAL PERSONNEL? THE SURGEON DOES NOT WANT TO SPEAK WITH MEDICAL PERSONNEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EIGHT DAYS AFTER A LAPAROSCOPIC GASTRECTOMY, THE PATIENT DIED BECAUSE OF INTERNAL BLEEDING FROM DAMAGED ARTERY. THE DAY BEFORE THE PATIENT DIED, THE PATIENT¿S BODY TEMPERATURE AND BLOOD PRESSURE WERE NORMAL. ACCORDING TO THE DOCTOR, IT IS POSSIBLE THAT THE CAUSE OF ARTERY DAMAGE WAS HARH36. THE DETAIL INFORMATION WILL BE REPORTED AS SOON AS IT IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788701 HARMONIC ACE + 7 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR & HANDPIECE