BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9465375 · Received December 13, 2019

    Report

    Report Number
    3005075853-2019-24253
    Event Type
    Injury
    Date Received
    December 13, 2019
    Report Date
    November 14, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2007. 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: LAPAROSCOPIC SIGMOID RESECTIONS FOR DIVERTICULITIS COMPLICATED BY ABSCESSES OR FISTULAS. AUTHOR(S): CHRISTINA ZAPLETAL, GUIDO WOESTE, WOLF O. BECHSTEIN, CHRISTOPH WULLSTEIN. CITATION: INT J COLORECTAL DIS (2007) 22:1515¿1521; DOI 10.1007/S00384-007-0359-Y. THIS STUDY AIMED TO COMPARE THE RESULTS OF LAPAROSCOPIC SIGMOID RESECTIONS IN PATIENTS WITH COMPLICATED VS RECURRENT DIVERTICULITIS CONCERNING PATIENT VARIABLES, STAGE OF DISEASE, OPERATIVE COURSE, MORBIDITY, MORTALITY AND HOSPITAL STAY. BETWEEN SEP2002 AND JAN2006, 58 PATIENTS WITH UNCOMPLICATED RECURRENT DIVERTICULITIS (N=32; N=19 MALE AND N=13 FEMALE; AGE OF 57.3±14.3 YEARS; ) AND DIVERTICULITIS COMPLICATED BY ABSCESS OR FISTULA (N=26; N=9 MALE AND N=17 FEMALE; AGE OF 60.1±12.9 YEARS) UNDERWENT LAPAROSCOPIC SIGMOID RESECTIONS. IN THE PROCEDURE, THE MOBILIZATION WAS PERFORMED USING THE MEDIAL APPROACH WITH MOBILIZATION OF THE MESENTERY OF THE SIGMOID AND THE DESCENDING COLON WITH THE USE OF ULTRACISION® (ETHICON ENDO SURGERY). IN ALL PATIENTS, THE LEFT URETHER WAS IDENTIFIED THEN, AND THE INFERIOR MESENTERIC ARTERY AND VEIN WERE DISSECTED BY CLIPS OR BY THE USE OF A LAPAROSCOPIC LINEAR STAPLING DEVICE. THEREAFTER, LATERAL MOBILISATION WAS PERFORMED. THE SPLENIC FLEXURE WAS MOBILISED WHEN NECESSARY (88%). CONVERSION WAS NECESSARY IN ONE OBESE PATIENT DUE TO BLEEDING AT THE MESENTERY WHICH COULD NOT BE TREATED LAPAROSCOPICALLY. POSTOPERATIVELY ONE BOWEL PERFORATION AT THE SPLENIC FLEXURE OCCURRED AT DAY 4, WHICH COULD BE TREATED BY SUTURE AND ABDOMINAL LAVAGE AFTER LAPAROTOMY. LAPAROSCOPIC SIGMOIDECTOMY CAN BE SUCCESSFULLY PERFORMED IN COMPLICATED DIVERTICULITIS INCLUDING FISTULISED DISEASE. CONVERSION SHOULD BE CONSIDERED AS SOON AS THERE IS STAGNATION OF THE OPERATION SO THAT THE COMPLICATION RATE IN CONVERTED PATIENTS DOES NOT EXCEED THE COMPLICATION RATE IN LAPAROSCOPICALLY TREATED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264652 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention