BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    MDR report key: 8204668 · Received December 28, 2018

    Report

    Report Number
    2210968-2018-78086
    Event Type
    Injury
    Date Received
    December 28, 2018
    Report Date
    December 7, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GEA
    PMA / PMN Number
    K925914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: SURG ENDOSC (2010) 24:2908¿2912; DOI 10.1007/S00464-010-1041-Y. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: INTRACORPOREAL CIRCULAR-STAPLED ESOPHAGOJEJUNOSTOMY USING HAND-SEWN PURSE-STRING SUTURE AFTER LAPAROSCOPIC TOTAL GASTRECTOMY". AUTHOR(S): TAKAHIRO KINOSHITA ¿ TAKASHI OSHIRO ¿ KATSUHIKO ITO ¿ HIDEHITO SHIBASAKI ¿ SHINICHI OKAZUMI ¿ RYOJI KATOH. CITATION: SURG ENDOSC (2010) 24:2908¿2912; DOI 10.1007/S00464-010-1041-Y. THIS STUDY AIMED TO ASSESS WHETHER A CIRCULAR-STAPLED ANASTOMOSIS USING HAND-SEWN PURSE-STRING SUTURE IS FEASIBLE FOR LAPAROSCOPIC TOTAL GASTRECTOMY (LTG). FROM SEP2008 TO MAY2009, 10 PATIENTS (N=9 MALE AND N=1 FEMALE; MEDIAN AGE OF 63.7 YEARS [RANGE 45-80 YEARS]) WITH GASTRIC CANCER UNDERWENT LTG. IN ALL CASES, ESOPHAGOJEJUNAL ANASTOMOSIS WAS PERFORMED USING ECS 25-MM CIRCULAR STAPLER. ENDOLOOP WAS APPLY TO REINFORCE THE LIGATION. POSTOPERATIVELY, ONLY ONE PATIENT EXPERIENCED INTRA-ABDOMINAL ABSCESS WHICH WAS TREATED CONSERVATIVELY WITH ANTIBIOTICS. ESOPHAGOJEJUNOSTOMY CAN BE PERFORMED AS IN CONVENTIONAL OPEN SURGERY. HAND-SEWN PURSE-STRING SUTURING IS DEMANDING TECHNICALLY, BUT IT CAN BE PERFORMED SAFELY BY EXPERIENCED LAPAROSCOPIC SURGEONS. THIS TECHNIQUE IS FEASIBLE AND CAN LOWER THE COST OF THE LAPAROSCOPIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041589 ENDOLOOP LIGATURE UNKNOWN PRODUCT CANNULA, SURGICAL, GENERAL GEA ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention