BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 8175989 · Received December 18, 2018

    Report

    Report Number
    2647580-2018-06169
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    November 20, 2018
    Report Date
    December 18, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523003543
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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, DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, WHEN THE SURGEON TRIED TO FIRE THE DEVICE AT THE FIRST FIR ING, THE DEVICE STOPPED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015291 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EGIAUSTND 10884523003543

    Patients

    Seq Age Sex Outcome Treatment
    1