BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH SHORT INSTRUMENT

    MDR report key: 2021602 · Received March 10, 2011

    Report

    Report Number
    1219930-2011-00193
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 11, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SACROSPINOUS COLPOPEXY. ACCORDING TO THE REPORTER: THE FIRST NEEDLE BROKE OFF THE SUTURE WHEN IT WAS BEING PASSED THROUGH THE LIGAMENT. THE NEEDLE DID NOT COME OUT OF THE PT. THE SECOND NEEDLE TIP BROKE OFF AS IT WAS BEING PASSED THROUGH THE LIGAMENT AND THE TIP DID NOT COME OUT OF THE PT. THE SURGEON SPENT 10 MINS LOOKING AROUND FOR THE NEEDLES BUT COULD NOT LOCATE THEM. THERE WAS NO ADDITIONAL BLOOD LOSS CAUSED BY THIS EVENT. THE SURGEON OPENED A NEW DEVICE AND COMPLETED THE PROCEDURE. AFTER THE SURGERY, THE PT WAS X-RAYED AND THE 3 BITS OF NEEDLE COULD BE SEEN ON THE X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SHORT INSTRUMENT DISPOSABLE SUTURING DEVICE KOG UNITED STATES SURGICAL N9M0414

    Patients

    Seq Age Sex Outcome Treatment
    1 Other