BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO STITCH SULU

    MDR report key: 4990239 · Received August 11, 2015

    Report

    Report Number
    1219930-2015-00722
    Event Type
    Injury
    Date Received
    August 11, 2015
    Report Date
    March 1, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HYSTERECTOMY. ACCORDING TO THE REPORTER: THE NEEDLE BROKE IN HALF AND AN X-RAY WAS USED TO FIND THE NEEDLE. IT WAS FOUND AND REMOVED. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS DELAYED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523520 UNKNOWN ENDO STITCH SULU SINGLE USE SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL A DIVISON

    Patients

    Seq Age Sex Outcome Treatment
    1 Other