BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA INSTRUMENT

    MDR report key: 9284338 · Received November 6, 2019

    Report

    Report Number
    2647580-2019-05515
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    January 31, 2019
    Report Date
    November 6, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: PROXIMAL JEJUNAL BYPASS IMPROVES THE OUTCOME OF GASTRIC CLIP IN PATIENTS WITH OBESITY AND TYPE 2 DIABETES MELLITUS. SOURCE: SEH-HUANG CHAO & CHIA-LIN LIN & WEI-JEI LEE & JUNG-CHIEN CHEN & JU JUN CHOU. DATE: PUBLISHED ONLINE: 29 JANUARY 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)].

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED ON PATIENTS UNDERWENT LAPAROSCOPIC GASTRIC CLIP (GC) AND PROXIMAL JEJUNAL BYPASS (PJB). THREE PATIENTS IN THE PJB-GC GROUP HAD TARRY-BLOOD STOOL POSTOPERATIVELY IN THE AMOUNT THAT TRANSFUSION OF PACKED RED BLOOD CELLS WAS REQUIRED. ONE PATIENT IN THE GC GROUP DEVELOPED LEFT-SIDE ATELECTASIS AND PLEURISY POSTOPERATIVELY WHICH RESOLVED AFTER CONSERVATIVE MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082370 UNKNOWN ENDO GIA INSTRUMENT STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN ENDO GIA INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other