BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-T II PORT CLOSURE 10/15

    MDR report key: 3080944 · Received April 24, 2013

    Report

    Report Number
    1216677-2013-00012
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 23, 2013
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE C-T II PORT CLOSURE, 10/15 (MM) INVOLVED IN THIS EVENT WAS NOT RETURNED TO COOPERSURGICAL FOR EVALUATION. THE COMPLAINT IS STILL UNDER INVESTIGATION BY OUR ENGINEERING DEPARTMENT. (B)(4).

    Description of Event or Problem · 1

    WHILE PUSHING THE SUTURE PASSER THROUGH THE 15MM PILOT GUIDE HOLE - SHAVINGS OF PLASTIC FELL INTO THE PATIENT. A ROBOTIC ARM AND 5MM GRASPER WERE USED TO RETRIEVE THE PLASTIC FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176958 C-T II PORT CLOSURE 10/15 NONE GCJ COOPERSURGICAL, INC. 135860

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention