BEUDAMED
    FDA Adverse Event Summary report: N

    KII 5X100 FIOS Z-THR

    MDR report key: 3030441 · Received March 26, 2013

    Report

    Report Number
    2027111-2013-00110
    Date Received
    March 26, 2013
    Date of Event
    January 21, 2013
    Report Date
    March 26, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP APPY - "THE SCOPE PLACED INTO THE TROCAR CREATED PLASTIC SHAVINGS WHICH ENDED UP INSIDE OF PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123315 KII 5X100 FIOS Z-THR NONE GCJ APPLIED MEDICAL CTF03 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1