BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURSTRING 45 TEMP/PERM INSTR

    MDR report key: 3843632 · Received May 27, 2014

    Report

    Report Number
    2647580-2014-00386
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDJ
    PMA / PMN Number
    K901107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: DURING USE, ONLY THE STAPLE WAS FIRED ON THE TISSUE AND THE SUTURE REMAINED IN THE INSTRUMENT. THEY CONDUCTED AN ADDITIONAL RESECTION OF THE CONCERNING PART OF FAILURE OF THE STAPLE LINE. A NEW ONE WAS OPENED TO COMPLETE THE CASE WITH NO PROBLEM. THERE WAS UNANTICIPATED TISSUE DAMAGE. THERE WAS NO BLEEDING OVER 500CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311817 PURSTRING 45 TEMP/PERM INSTR DISPOSABLE SUTURING DEVICE GDJ COVIDIEN, FORMERLY USSC P3C0338X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other