BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 4093129 · Received September 10, 2014

    Report

    Report Number
    9612501-2014-00294
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 20, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE NEEDLE WOULDN'T STAT ATTACHED TO UNIT. CORRECT STEPS FOLLOWED. ADD'L INFO REQUESTED VIA EMAIL: WHEN YOU SAY THE "NEEDLE WOULDN'T STAT ATTACHED," DO YOU MEAN THE USER WAS UNABLE TO LOAD THE NEEDLE ONTO THE DEVICE, OR THE NEEDLE BECAME DETACHED WHILE IN USE ON THE PT?, IF THE NEEDLE BECAME DETACHED, DID IT FALL INTO THE PT'S CAVITY?, IF SO, WAS THE NEEDLE RETRIEVED?, IF SO, WAS AN X-RAY TAKEN IN ORDER TO LOCATE AND RETRIEVE THE NEEDLE?, WAS THERE AN EXTENSION IN THE SURGICAL INCISION BY MORE THAN 1 INCH?, WAS THERE ANY TISSUE DAMAGE?, WAS THERE ANY BLOOD LOSS GREATER THAN 500CC?.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559675 ENDO STITCH 10MM SUTURING DEVICE SINGLE USE SUTURE DEVICE KOG COVIDIEN J4B0855X

    Patients

    Seq Age Sex Outcome Treatment
    1