BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH PLYSORB 0 48 VIO DLU SU

    MDR report key: 3133947 · Received May 1, 2013

    Report

    Report Number
    1219930-2013-00322
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY US SURG
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: NEEDLE BROKE. NEEDLE FRAGMENT FELL INTO THE CAVITY. NO DEVICE FRAGMENT OR COMPONENT WAS LEFT IN THE PT. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190983 ENDO STITCH PLYSORB 0 48 VIO DLU SU SURGICAL SUTURING DEVICE KOG COVIDIEN LP, FORMERLY US SURG

    Patients

    Seq Age Sex Outcome Treatment
    1