BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KII 5 X 100 FIOS Z-THR

    MDR report key: 2543025 · Received April 11, 2012

    Report

    Report Number
    2027111-2012-00103
    Event Type
    Injury
    Date Received
    April 11, 2012
    Date of Event
    March 22, 2012
    Report Date
    April 11, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED WITHIN 30 DAYS OR 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 PROSTATECTOMY - "5 HOURS INTO THE CASE THERE WAS SIGNIFICANT LEAKING THROUGH THE SEALS OF 5 APPLIED MEDICAL TROCARS. IT WAS 4 TIMES (B)(4) LOT NUMBER - 1160784; 1 TIME (B)(4) LOT NUMBER - 1158737. THE LEAKING PERSISTED CAUSING THE SURGEON TO BE UNABLE TO KEEP THE PATIENTS ABDOMEN INSUFFLATED. ALL 5 TROCAR SEALS WERE CHANGED AND THE LEAKING STOPPED." PATIENT STATUS: NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KII 5 X 100 FIOS Z-THR NONE GCJ APPLIED MEDICAL CTF03 1160784

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) - LOT# 1158737| (B)(4) FIOS Z-THREADED