BEUDAMED
    FDA Adverse Event Summary report: N

    FLEXI PATH SURGICAL TROCER

    MDR report key: 3770924 · Received April 21, 2014

    Report

    Report Number
    MW5035752
    Date Received
    April 21, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 18, 2014
    Manufacturer
    ETHICON
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT VIDEO ASSISTED THORACOSCOPIC SURGERY ON (B)(6) 2013. A CT SCAN PERFORMED ON (B)(6) 2014, DUE TO SHORTNESS OF BREATH, REVEALED A FOREIGN OBJECT PRESENT IN THE PT'S POSTERIOR RIBCAGE. THE PT UNDERWENT EXPLORATORY SURGERY ON (B)(6) 2014, AT WHICH TIME A PORTION OF A TROCAR SLEEVE WAS IDENTIFIED AND REMOVED. IT IS NOT KNOWN IF THIS INCIDENT WAS DUE TO DEVICE MALFUNCTION OR USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241669 FLEXI PATH SURGICAL TROCER FLEXIPATH SURTICAL TROCAR GCJ ETHICON FP020

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization