BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIDAC

    MDR report key: 7328506 · Received March 9, 2018

    Report

    Report Number
    9612501-2018-00474
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 20, 2018
    Report Date
    March 9, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    OCW
    UDI-DI
    20884521129433
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: OCCURRED DURING A LAPAROSCOPIC MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) PROCEDURE. THE SUTURING DEVICE WAS DIFFICULT TO LOAD AND UNLOAD. THERE WERE NO ISSUES USING THE DEVICE. FOUR NEEDLES ALSO BROKE. ONE HALF OF THE NEEDLE IS STILL LOADED IN THE DEVICE. ALL OF THE NEEDLE WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170729 SURGIDAC ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD 173021 J7H1699X 20884521129433

    Patients

    Seq Age Sex Outcome Treatment
    1