BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 6788373 · Received August 11, 2017

    Report

    Report Number
    9612501-2017-05937
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Report Date
    August 25, 2017
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    OCW
    UDI-DI
    10884521100008
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PRODUCT CODE: OCW; COMMON DEVICE NAME: ENDOSCOPIC TISSUE APPROXIMATION DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE. THE SUTURING DEVICES WERE BEING USED TO OVERSEW THE SLEEVE. THE SUTURING DEVICES WERE DIFFICULT TO TOGGLE, DIFFICULT TO LOAD, AND DIFFICULT TO UNLOAD. IN ORDER TO RESOLVE THE ISSUES AND COMPLETE THE CASE, OPENED A NEW SUTURING DEVICE. THERE WAS NO PATIENT HARM. THE PATIENT STATUS IS ALIVE, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568210 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD 173016 J6K1896X 10884521100008

    Patients

    Seq Age Sex Outcome Treatment
    1