BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE + 7

    MDR report key: 4102920 · Received September 19, 2014

    Report

    Report Number
    3005075853-2014-06539
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 8, 2014
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED: WHAT WAS THE PROCEDURE? ANTRECTOMY (LEFT HEMICOLECTOMY). HOW LONG AFTER THE PROCEDURE DID THE BLEEDING OCCUR (PROVIDED NUMBER OF HOURS, DAYS, ETC.)? AFTER 12H. WHICH VESSEL WAS THE BLEEDING FROM? (A NAMED VESSEL?) LEFT GASTROEPIPLOIC VESSEL. WAS ADVANCED HEMOSTASIS MODE USED FOR THE FULL TRANSECTION? IT WAS USED THE ADVANCED HEMOSTATIC FUNCTION OF HARMONIC 7. WAS AN EXPLORATORY DONE OR A 2ND PROCEDURE TO CONTROL THE BLEEDING? IT WAS NECESSARY A RE-INTERVENTION TO MONITOR THE HEMORRHAGE. IF YES, WHERE WAS THE BLEEDING FROM? (NO ANSWER GIVEN). HOW MUCH BLOOD WAS LOST? (CC¿S)ABOUT 800 CC. WAS A TRANSFUSION REQUIRED? 3 PACKETS CELLS. WHAT WAS THE SIZE OF THE VESSEL OR ARTERY? 3 MM. WHAT SYMPTOMS DID THE PATIENT PRESENT WITH TO INDICATE POST-OP BLEEDING? HEMORRHAGIC SHOCK. WAS THE PATIENT STILL IN THE HOSPITAL WHEN THE POST-OP BLEEDING OCCURRED? YES.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. DEVICE EVALUATION - NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN UNKNOWN PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583592 HARMONIC ACE + 7 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE