BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* SURGIDAC*2/0 48 GRN DLU SU

    MDR report key: 4909345 · Received July 13, 2015

    Report

    Report Number
    1219930-2015-00532
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 29, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    OCW
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) CONDUCTED AN EVALUATION OF ONE ENDO STITCH SURGIDAC*2/0 48 GRN DLU SU OPENED BY THE ACCOUNT. THE VISUAL INSPECTION OF THE SAMPLE NOTED NO ABNORMALITIES. A PMV REPRESENTATIVE INSTRUMENT WAS LOADED WITH THE RECEIVED SAMPLE SUTURE AND SUCCESSFULLY APPLIED TO TEST MEDIA. THE NEEDLE TOGGLED LEFT AND RIGHT WITHOUT DIFFICULTY. PRESSURE WAS EXERTED ON THE NEEDLE IN ALL DIRECTIONS FROM BOTH SIDES TO SIMULATE CLINICAL CONDITIONS AND NO DIFFICULTY WAS EXPERIENCED IN LOADING, UNLOADING, OR TOGGLING OF THE INSTRUMENT. THE RETURNED SAMPLE, AS RECEIVED, WAS FOUND TO MEET QUALITY RELEASE SPECIFICATIONS AFTER APPLICATION IN THE CLINICAL SETTING, AND THE REPORTED CONDITION WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED

    Description of Event or Problem · 1

    PROCEDURE: ROUX-EN-Y ANATOMY INVOLVED: MESENTERY ACCORDING TO THE REPORTER: WHEN THE SURGEON WAS CLOSING THE MESENTERY THERE WAS A DEFECT WITH THE ENDO STITCH ON A LGB CASE. HE PASSED THE NEEDLE FROM ONE JAW TO THE OTHER JAW AND THE NEEDLE DISENGAGED FROM THE ENDO STITCH INSTRUMENT. HE CUT THE SUTURE TO REMOVE THE NEEDLE FROM THE PATIENTS ABDOMEN. THE SCRUB TECH RELOAD THE ENDO STITCH WITH ANOTHER DLU TO FINISH THE PROCEDURE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453614 ENDO STITCH* SURGIDAC*2/0 48 GRN DLU SU SINGLE USE SUTURING DEVICE OCW COVIDIEN, FORMERLY US SURGICAL A DIVISON 173023

    Patients

    Seq Age Sex Outcome Treatment
    1