BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 4203553 · Received September 17, 2014

    Report

    Report Number
    9612501-2014-00330
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE DOCTOR WAS SUTURING WITH THE DEVICE AND THE NEEDLE FELL OFF. NEEDLE WAS ABLE TO BE RECOVERED, HOWEVER, DOCTOR HAD TO USE ANOTHER ENDO STITCH TO COMPLETE THE PROCEDURE. THERE WAS NO ANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED EXTENSION FOR THE INCISION MORE THAN ONE INCH. THER WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS NO DELAY OVER 30 MINUTES. NO DEVICE FRAGMENT FELL IN THE PATIENT CAVITY. NO DEVICE FRAGMENT WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575484 ENDO STITCH 10MM SUTURING DEVICE SINGEL USE SUTURING DEVICE KOG COVIDIEN J4B1445X

    Patients

    Seq Age Sex Outcome Treatment
    1