BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-T II PORT CLOSURE, 10/15 (MM)

    MDR report key: 3061205 · Received April 10, 2013

    Report

    Report Number
    1216677-2013-00009
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 10, 2013
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    KOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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

    DURING A DAVINCI PROSTATECTOMY A PIECE OF PLASTIC WAS SHAVED OFF THE C-T PORT CLOSURE SUTURE GUIDE. THE PLASTIC SHAVING FELL INTO THE PT'S ABDOMEN. THE PHYSICIAN WAS ABLE TO RETRIEVE THE SHAVING WITH A SUTURE GRASPER AND COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148191 C-T II PORT CLOSURE, 10/15 (MM) NONE KOH COOPERSURGICAL, INC. 138382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention