BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9520006 · Received December 26, 2019

    Report

    Report Number
    3005075853-2019-24749
    Event Type
    Injury
    Date Received
    December 26, 2019
    Date of Event
    January 1, 2011
    Report Date
    November 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/26/2019. DATE OF EVENT: PUBLICATION YEAR OF 2011. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    TITLE: USE OF THE NEW ULTRASONICALLY CURVED SHEAR IN PANCREATICODUODENECTOMY FOR PERIAMPULLARY CANCER. AUTHORS: SOHEI SATOI; HIROAKI YANAGIMOTO; HIDEYOSHI TOYOKAWA. CITATION: J HEPATOBILIARY PANCREAT SCI (2011) 18:609¿614; DOI 10.1007/S00534-011-0370-0. THE AIMED OF THIS PROSPECTIVE STUDY WAS TO EXAMINE WHETHER THE USE OF THE NEW ULTRASONICALLY CURVED SHEAR (UCS) CAN REDUCE THE NUMBER OF SURGICAL STITCHES, EXTENT BLOOD LOSS, AND OPERATION TIME IN (PYLORUS-PRESERVING) PANCREATICODUODENECTOMY (PD) FOR PERIAMPULLARY CANCER. FROM SEPTEMBER 2009 TO APRIL 2010, 26 PATIENTS WITH PERIAMPULLARY CANCER UNDERWENT PD, INCLUDING PPPD. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: GROUP A CONSISTED OF 13 CONSECUTIVE CANCER PATIENTS (MALE=10, FEMALE=3; MEAN AGE=64 YEARS, AGE RANGE=50-81 YEARS) WHO UNDERWENT CONVENTIONAL PD. GROUP B CONSISTED OF 13 PATIENTS (MALE=8, FEMALE=5; MEAN AGE=72 YEARS, AGE RANGE=38-86 YEARS) USING THE UCS FOR DISSECTION. UCS ¿ HARMONIC FOCUS (ETHICON) WAS USED IN THE PROCEDURE. REPORTED COMPLICATIONS INCLUDED MEAN BLOOD LOSS OF 790 ML (RANGE 239-1664 ML) (N=13) IN WHICH TRANSFUSION WAS PERFORMED TO 7 PATIENTS; SEPTIC COMPLICATIONS (N=2); AND PANCREATIC FISTULA (N=5). IN CONCLUSION, THE USE OF THE NEW UCS IN PD WAS SAFE PROCEDURE AND ASSOCIATED WITH THE ECONOMICAL BENEFIT OF FEWER SURGICAL STITCHES AS WELL AS WITH REDUCED BLOOD LOSS AND REDUCED OPERATIVE TIME SPENT DURING THE HILAR PART OF PD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315570 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1