BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSASTEP 5MM SGLUSE SHORT DIL/CANN EXPSL

    MDR report key: 4604858 · Received March 16, 2015

    Report

    Report Number
    9612501-2015-00143
    Event Type
    Malfunction
    Date Received
    March 16, 2015
    Date of Event
    February 13, 2015
    Report Date
    March 5, 2015
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K012539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON 03/16/2015.

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP REPORT SENT TO FDA ON 03/24/2015. BASED ON REVIEW OF THE FILE, THIS REPORT WAS DETERMINE TO BE A NON-REPORTABLE EVENT. THE FILE HAS BEEN UPDATED FROM A MALFUNCTION TO A COMPLAINT.

    Description of Event or Problem · 1

    PROCEDURE: DEVICE WAS NOT USED ON A PATIENT OR IN A CLINICAL SETTING. DEVICE WAS TESTED IN AN INTERNAL LAB. ACCORDING TO THE REPORTER: DURING DQA TESTING - 2 DEVICES [REF. (B)(4)] GOT CAUGHT BEING INSERTED THROUGH A 5MM PORT DURING TESTING. REF VS100705 (LOT: J4M0009X) IN ADDITION, MULTIPLE UNITS REQUIRED EXCESSIVE FORCE TO INSERT/REMOVE THE DEVICES AND THE PROCESS WAS NOT AS SMOOTH AS IT SHOULD HAVE BEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178527 VERSASTEP 5MM SGLUSE SHORT DIL/CANN EXPSL DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN VS100705 J4M0009X

    Patients

    Seq Age Sex Outcome Treatment
    1