BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-T II PORT CLOSURE, 10/12 (MM)

    MDR report key: 3123878 · Received May 15, 2013

    Report

    Report Number
    1216677-2013-00015
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 15, 2013
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE C-T II PORT CLOSURE, 10/12 (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 ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY, THE DOCTOR WAS USING THE C-T II AND THE TIP OF THE PASSER SCRAPED THE SIDE OF THE PILOT GUIDE. A SHAVING ENDED UP IN THE ANTERIOR WALL OF HER ABDOMINAL CAVITY. THE DOCTOR DID GO BACK IN THROUGH ANOTHER PORT TO RETRIEVE IT, PATIENT WAS REPORT AS COMPLETELY FINE AND UNAFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214589 C-T II PORT CLOSURE, 10/12 (MM) LAPAROSCOPIC PORT-SITE CLOSURE GCJ COOPERSURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1