BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA*21 INST W/O TILT-TOP*

    MDR report key: 5845028 · Received August 3, 2016

    Report

    Report Number
    2647580-2016-00559
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    July 12, 2016
    Report Date
    July 13, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER: (B)(6). USER FACILITY PHONE NUMBER: (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE STAPLE DID NOT FORM PROPERLY WHEN ANASTOMOSING THE INTESTINE DURING A COLORECTAL PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE, THEN ANOTHER 111983 WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS UNANTICIPATED TISSUE LOSS. IT WAS UNKNOWN IF REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496582 PREMIUM PLUS CEEA*21 INST W/O TILT-TOP* STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC 111983 P2K0219X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S