BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH 10MM SUTURING DEVICE

    MDR report key: 2990020 · Received February 25, 2013

    Report

    Report Number
    1219930-2013-00115
    Event Type
    Injury
    Date Received
    February 25, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 29, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA. ACCORDING TO THE REPORTER: WHEN USING THE COVIDIEN ENDOSTITCH WITH A 2-0 SURGIDAC SUTURE TO PLACE MESH WITHIN THE PT'S ABDOMEN. WHEN PULLING DEVICE OUT, THE SUTURE STAYED WITHIN THE TISSUE AND MESH INSIDE THE PT. SURGEON DID NOT RETRIEVE STATING, TO EXPLORE AND REMOVE SUTURE WOULD CAUSE MORE HARM TO PT THAN LEAVING THE NEEDLE ALONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79320 ENDO STITCH 10MM SUTURING DEVICE SURGICAL SUTURING DEVICE KOG COVIDIEN, FORMERLY US SURGICAL N2J0589X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other