BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH*POLYSORB* 2/0 48 VIO DLU SU

    MDR report key: 4200494 · Received October 24, 2014

    Report

    Report Number
    1219930-2014-00976
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    October 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GASTROINTESTINAL.ACCORDING TO THE REPORTER: THE SUTURE DETACHED FROM THE NEEDLE IN TWO DIFFERENT CASES WHEN THE USER WAS PERFORMING A GASTRIC ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678808 ENDO STITCH*POLYSORB* 2/0 48 VIO DLU SU SINGLE USE SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL A DIVISON 170053 B3L0484X

    Patients

    Seq Age Sex Outcome Treatment
    1