BEUDAMED
    FDA Adverse Event Summary report: N

    KII 12X100 FIOS Z-THR HN 6/BX

    MDR report key: 2940931 · Received January 30, 2013

    Report

    Report Number
    2027111-2013-00019
    Date Received
    January 30, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 30, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    LAPAROSCOPIC CHOLECYSTECTOMY - "A PIECE OF DOUBLE DUCKBILL SEAL WAS FOUND IN PATIENTS LIVERBED AT THE END OF THE CASE PRIOR TO CLOSING. THE PIECE OF THE SEAL WAS SUCCESSFULLY REMOVED PRIOR TO CLOSING." PATIENT STATUS: NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41625 KII 12X100 FIOS Z-THR HN 6/BX NONE GCJ APPLIED MEDICAL CTF74 1179571

    Patients

    Seq Age Sex Outcome Treatment
    1