BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIPORT PLUS

    MDR report key: 7568664 · Received June 5, 2018

    Report

    Report Number
    7568664
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 18, 2018
    Report Date
    May 30, 2018
    Manufacturer
    COVIDIEN LLC
    Product Code
    GCJ
    UDI-DI
    10884521080645
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    WHILE INSERTING THE VISIPORT, SURGEON NOTICED THAT A SMALL PIECE OF PLASTIC HAD BROKEN OFF OF THE PORT. IT WAS ON THE DRAPES, REMOVED AND TAKEN OFF OF THE FIELD. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, VISIPORT PLUS (PER SITE REPORTER): UNKNOWN.

    Description of Event or Problem · 1

    WHILE INSERTING THE VISIPORT, SURGEON NOTICED THAT A SMALL PIECE OF PLASTIC HAD BROKEN OFF OF THE PORT. IT WAS ON THE DRAPES, REMOVED AND TAKEN OFF OF THE FIELD. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, VISIPORT PLUS (PER SITE REPORTER), UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413810 VISIPORT PLUS LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ COVIDIEN LLC 176673PF 10884521080645

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR