BEUDAMED
    FDA Adverse Event Summary report: N

    12X100MM KII CANNULA & SEAL THREADED 12/BOX

    MDR report key: 2895014 · Received December 27, 2012

    Report

    Report Number
    2027111-2012-00404
    Date Received
    December 27, 2012
    Date of Event
    December 17, 2012
    Report Date
    December 27, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A F/U REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADD'L INFO, 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

    ANTERIOR RESECTION - "LARGE SWAB WAS INSERTED INTO THE HOUSING UNIT AND THE SEAL BECAME DETACHED AND FELL INSIDE THE PT. THE SEAL WAS THEN REMOVED FROM INSIDE THE PT AND THE TROCAR REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100MM KII CANNULA & SEAL THREADED 12/BOX 12X100MM KII CANNULA & SEAL THREADED 12/BOX GCJ APPLIED MEDICAL C0R73 NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 LARGE SWAB