BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA* 31 INSTR. W/TILT-TOP*

    MDR report key: 1070904 · Received June 30, 2008

    Report

    Report Number
    2647580-2008-00367
    Event Type
    Injury
    Date Received
    June 30, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 16, 2008
    Manufacturer
    PONCE-USS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION WITH END-TO-END ANASTOMOSIS. ACCORDING TO THE REPORTER: WHEN THE SURGEON TRIED TO CONNECT THE ANVIL TO THE DEVICE, THE WING-NUT COULD NOT BE ROTATED. THE ANVIL COULD NOT BE CONNECTED AND A DAMAGE TO COLON WAS OBSERVED. THE AREA WAS RESECTED AND ANOTHER INSTRUMENT WAS APPLIED. AFTER THE APPLICATION THE ANTERIOR WALL HAD 1-2CM HOLE AND THE DISTAL DONUT TISSUE WAS MALFORMED. THE SURGERY WAS SUBSEQUENTLY CHANGED TO MILES OPERATION FOR COMPLETION. NO BLEEDING WAS REPORTED, AND NO PT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA* 31 INSTR. W/TILT-TOP* DISPOSABLE SURGICAL STAPLER GDW PONCE-USS P7L0821J

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R