BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH SURGIDAC 0 48 GRN DLU SU

    MDR report key: 3170439 · Received May 24, 2013

    Report

    Report Number
    9612501-2013-00052
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    April 25, 2013
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    HAD 3 ENDO-STITCH RELOADS WHERE THE NEEDLE COMPLETELY DETACHED FROM THE SUTURE. NEEDLE WAS REMOVED FROM PATIENT'S CAVITY. NO X-RAY WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230790 ENDO STITCH SURGIDAC 0 48 GRN DLU SU SURGICAL SUTURING DEVICE KOG COVIDIEN J2J0086X

    Patients

    Seq Age Sex Outcome Treatment
    1