BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 4433516 · Received January 20, 2015

    Report

    Report Number
    9612501-2015-00028
    Event Type
    Injury
    Date Received
    January 20, 2015
    Date of Event
    January 6, 2015
    Report Date
    January 6, 2015
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP REPORT SENT TO FDA ON 04/17/2015.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: DR (B)(6) USED ENDOSTITCH WITH POLYSORB RELOAD. INSTRUMENT WAS LOADED FOR DR. (B)(6) AND PASSED OFF FOR USE. AFTER FIRST NEEDLE PASS, DR (B)(6) NOTICED THE NEEDLE IN THE ENDOSTITICH WAS PRESENTING WITH 90 DEGREE (RIGHT-ANGLE) BEND. DR. (B)(6) IMMEDIATELY REMOVED ENDOSTITCH FROM PATIENT. AFTER THE ENDOSTITCH WAS REMOVED DR. (B)(6) AND OR STAFF OBSERVED THAT THE SUTURE WAS NOT ON THE ENDOSTITCH. DR. (B)(6) THEN RETRIEVED AND REMOVED THE SUTURE. AFTER REMOVAL, DR. (B)(6) OBSERVED THAT THE NEEDLE WAS NO LONGER ON THE SUTURE. DR. (B)(6) AND STAFF THEN EXECUTED ALL REQUIRED PROTOCOLS TO RETRIEVE THE NEEDLE. LOCATION AND REMOVAL WAS NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45943 ENDO STITCH* 10MM SUTURING DEVICE SINGLE USE SUTURING DEVICE KOG COVIDIEN 173016 J4H1159X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other