BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH POLYSORB 0 48 VIO DLU SU

    MDR report key: 3001303 · Received March 6, 2013

    Report

    Report Number
    1219930-2013-00135
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 11, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GYNECOLOGY. ACCORDING TO THE REPORTER: SACROSPINOUS PROCEDURE. ENDOSTITCH WITH POLYSORB RELOAD. FIRST STITCH OK. SECOND ONE NEEDLE SNAPPED IN HALF SO THAT HALF STAYED IN THE SACROSPINOUS LIGAMENT AND HALF CAME OUT. HAVE CONTACTED THE SURGEON BUT HAVE NOT HAD THE CHANCE TO SPEAK TO HER DIRECTLY YET BUT SPOKE TO THE SCRUB NURSE. PATIENT FOCUSED RESOLUTION OF EVENTS AND OUTCOMES CORRECTIVE ACTION TAKEN RELEVANT TO THE CARE OF THE PATIENT: SURGEON COULD NOT FIND THE PIECE OF METAL NEEDLE PATIENT THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96143 ENDO STITCH POLYSORB 0 48 VIO DLU SU SURGICAL SUTURING DEVICE KOG COVIDIEN, FORMERLY US SUR N2A0873YX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other