BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH PLYSORB 0 48 VIO DLU SU

    MDR report key: 3080698 · Received April 9, 2013

    Report

    Report Number
    1219930-2013-00261
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HYSTERECTOMY. ACCORDING TO THE REPORTER: THE NEEDLE BROKE IN THE MIDDLE AT THE SUTURE JUNCTION. REMOVED DEVICE AND FINISHED WITH ANOTHER. 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. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148072 ENDO STITCH PLYSORB 0 48 VIO DLU SU SURGICAL SUTURIN GDEVICE KOG COVIDIEN, FORMERLY US SUR B2H0934X

    Patients

    Seq Age Sex Outcome Treatment
    1