BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM PLUS CEEA

    MDR report key: 7443829 · Received April 19, 2018

    Report

    Report Number
    2647580-2018-01939
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    April 4, 2018
    Report Date
    April 19, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    20884523006619
    PMA / PMN Number
    K001895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    K001895. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC COLECTOMY PROCEDURE, WHILE THE DEVICE WAS BEING APPLIED AT THE ANASTOMOSIS SITE, THE SAFETY WOULD NOT RELEASE AND THE ANVIL AND ROD WERE NOT LINING UP PROPERLY, SO THE STAPLER COULD NOT BE FIRED. IT WAS ALSO NOTED THAT THE DEVICE WAS DIFFICULT OR UNABLE TO OPEN. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287726 PREMIUM PLUS CEEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO 111989 P5M0067X 20884523006619

    Patients

    Seq Age Sex Outcome Treatment
    1