BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 8110059 · Received November 28, 2018

    Report

    Report Number
    9612501-2018-02120
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    October 30, 2018
    Report Date
    February 25, 2019
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    OCW
    UDI-DI
    10884521100008
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL INSPECTION AND FUNCTIONAL TESTING CONFIRMED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EX-Y, WHILE CLOSING THE ENTEROTOMY OF THE JEJUNUM, ONE HALF OF THE NEEDLE FELL INTO THE PATIENT'S CAVITY. THE DOCTOR RETRIEVED THE BROKEN NEEDLE USING A GRASPER. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951673 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD 173016 J8F0055EX 10884521100008

    Patients

    Seq Age Sex Outcome Treatment
    1