BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT¿ PLUS V2

    MDR report key: 2223218 · Received August 17, 2011

    Report

    Report Number
    2223218
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 17, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    UPON REMOVING THE 15-MM PORT, IT DID APPEAR THAT A 3 X 3 MM PORTION OF THE SHEATH WAS NOT ATTACHED TO THE SHEATH. WE REINSERTED THE LAPAROSCOPE AND CAREFULLY INSPECTED THE ENTIRETY OF THE PERITONEUM TO ATTEMPT TO IDENTIFY THIS. THE PIECE OF PLASTIC WAS NOT IDENTIFIED WITHIN THE PERITONEUM. WE THEN INSPECTED THE SUBCUTANEOUS TISSUES AND THERE WAS NO FOREIGN BODY IDENTIFIED WITHIN THESE. I SUSPECT THAT THIS MAY HAVE COME OFF AS WE WITHDREW THE SHEATH AND PLACED IT ON THE OPERATIVE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPORT¿ PLUS V2 TROCAR GCJ COVIDIEN VERSAPORT PLUS 10MM -15MM P9D0166

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR