BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36

    MDR report key: 17404385 · Received July 27, 2023

    Report

    Report Number
    3005075853-2023-05334
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    July 13, 2023
    Report Date
    July 27, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036014621
    PMA / PMN Number
    K132612
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/27/2023. D4 BATCH #: UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THERE ANY DIFFICULTY WITH HEMOSTASIS DURING INITIAL PROCEDURE? THE SURGEON SAID THE PATIENT WAS OOZY. WHAT WAS THE APPROXIMATE SIZE OF THE GASTROCOLIC LIGAMENT? UNKNOWN. WHAT WAS THE POWER LEVEL THAT WAS USED AND WAS ADVANCED HEMOSTASIS MODE USED FOR THE HARMONIC DEVICE? THE SETTING IS ON 3 AND 5. AND UNKNOWN IF ADVANCED HEMOSTASIS BUTTON WAS UTILIZED. HOW WAS IT DETERMINED THAT THE BLEEDING OCCURRED? MY UNDERSTANDING POST OPERATIVELY IN THE NIGHT. WERE ANY SCANS OR IMAGING PERFORMED TO DETERMINE THE SITE OF BLEEDING? UNKNOWN. WHAT WAS THE SITE OF THE BLEEDING? ACCORDING TO SURGEON, ¿THE BLEEDING SITE WAS FROM THE CUT EDGE OF THE GASTROCOLIC LIGAMENT. WHAT IS THE SURGEON'S STANDARD BLOOD THINNING REGIMEN? IN ADDITION TO HARMONIC COAGULATION, HE USES ER320 FOR LIGATION AND HAS BEEN KNOW TO USE VISTASEAL IF THE COMORBIDITIES POSE A REBLEEDING RISK. WHAT IS THE PATIENT'S CURRENT STATUS? UNKNOWN. ANY ISSUES WITH STAPLE LINE OR STAPLE FORMATION? NONE. HE SAW SURGEON YESTERDAY AND PATIENT DOING GOOD. WHEN HE COAGULATED THE CUT EDGE OF THE GASTROCOLIC LIGAMENT, HE FOLLOWED UP WITH VISTASEAL VST10 TO FINISH THE THE RE-OP CASE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 24 HOURS POST OP TO A LAPAROSCOPIC GASTRIC SLEEVE THE PATIENT HAD SOME BLEEDING/OOZING FROM THE CUT EDGE OF THE GASTROCOLIC LIGAMENT. THE OMENTUM HAD BEEN SEWED TO THE STOMACH. SHE WAS GIVEN ONE UNIT OF BLOOD AND IS UNDER OBSERVATION. NO BUTTRESSING WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258126 HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. 10705036014621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GENERATOR