BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 7789400 · Received August 16, 2018

    Report

    Report Number
    1219930-2018-04533
    Event Type
    Injury
    Date Received
    August 16, 2018
    Date of Event
    July 31, 2018
    Report Date
    January 3, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: HEALTH PROFESSIONAL (HPRO). (THEY REDO THE OPERATION TO STOPPED THE BLEEDING). 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, POST OPERATIVELY, ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, THERE WAS BLEEDING FOUND IN THE STAPLE LINE. THEY REDO THE SURGERY TO STOP THE BLEEDING RESULTING TO TISSUE LOSS AND DAMAGE WHICH IS A PERMANENT INJURY. PATIENT WAS PLACE IN THE ICU AFTER THAT SECOND SURGERY THAT EXTENDS HOSPITAL STAY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, POST OPERATIVELY, ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, THERE WAS BLEEDING FOUND IN THE STAPLE LINE. THERE WAS A NEED TO GO BACK IN AS THE PRIMARY DOCTOR SAID THERE WAS A BLEEDING IN STAPLE LINE. HOWEVER SINCE THE PATIENT¿S RELATIVES WERE UNHAPPY, THE PATIENT WAS TRANSFERRED TO NUH. THERE HE WAS OPERATED AGAIN. UPON CONFIRMING WITH THE DOCTOR WHO OPERATED IN NUH, THE DOCTOR CLEARLY STATED THAT IT WAS THE STAPLER AT FAULT AND THAT WE HAD NOTHING TO WORRY ABOUT. THEY REDO THE SURGERY TO STOP THE BLEEDING RESULTING TO TISSUE LOSS AND DAMAGE WHICH IS A PERMANENT INJURY. PATIENT WAS PLACE IN THE ICU AFTER THAT SECOND SURGERY THAT EXTENDS HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633020 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT N8D0519KX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R