BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 7341688 · Received March 15, 2018

    Report

    Report Number
    1219930-2018-01487
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    January 17, 2018
    Report Date
    January 29, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED A PHOTOGRAPHIC EVALUATION OF A DEVICE AND MESH BEING USED INTRA-OPERATIVELY. A VISUAL INSPECTION OF THE RETURNED PHOTOS NOTED A DEVICE AND MESH BEING USED INTRA-OPERATIVELY. NO DEVICE WAS OBSERVED IN ANY PHOTOS. NO STAPLES WERE OBSERVED IN ANY PHOTOS. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH REGARD TO THE REPORTED CONDITION. WITHOUT THE PHYSICAL PRODUCT, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE ISSUE OCCURRED AFTER A GASTRIC SLEEVE PROCEDURE WHEREIN A FISTULA FORMED AT THE GASTRIC FUNDUS. RE-SURGERY WITH ESOPHAGEAL PROSTHESIS POSITIONING WAS DONE TO RESOLVE THE ISSUE. THE PATIENT HOSPITALIZATION WAS EXTENDED FOR ONE WEEK DUE TO THE PROBLEM.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, POST OPERATIVELY, ON A LAPAROSCOPIC GASTRIC SLEEVE ON THE GASTRIC FUNDUS, A FISTULA FORMED. RE-SURGERY WITH ESOPHAGEAL PROSTHESIS POSITIONING WAS DONE TO RESOLVE THE ISSUE. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED FOR ONE WEEK. THERE WAS TEMPORARY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187011 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AXT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R