BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KII 12X100 FIOS Z-THREADED

    MDR report key: 3930275 · Received July 11, 2014

    Report

    Report Number
    2027111-2014-00294
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    March 3, 2014
    Report Date
    September 8, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K041795
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE INCIDENT PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER WAS PROVIDED. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE INCIDENT AND RELATED PRODUCTS. AT THIS TIME, APPLIED MEDICAL IS UNABLE TO DETERMINE THE CAUSE OF THE INJURY OR CONFIRM THAT A PRODUCT MALFUNCTION OCCURRED. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Description of Event or Problem · 1

    LAPAROSCOPIC HEMIFUNDOPLICATION- "PATIENT WAS BROUGHT FORWARD FOR ROUTINE ELECTIVE LAPAROSCOPIC HEMIFUNDOPLICATION. THE KII FIOS ENTRY PORT WAS PLACED IN THE LEFT UPPER QUADRANT WITH A SKIN INCISION FOLLOWED BY DIRECT ENTRY USING THE LAPAROSCOPIC CAMERA WITHIN THE PORT TO CAREFULLY DETERMINED SEPARATION OF THE TISSUE LAYERS. ON WITHDRAWAL OF THE CAMERA AND THE TROCAR BLOOD WAS NOTED TO BECOMING FROM THE PORT. A SECOND PNEUMOPERITONEUM WAS ESTABLISHED AND A SECOND 10MM LAPAROSCOPIC PORT WAS INSERTED INTO THE LEFT UPPER QUADRANT UNDER DIRECT VISION. USING THE CAMERA PORT AND INSTRUMENTS VIA THE SECOND PORT THE INJURIES WERE DETERMINED WHICH INCLUDED A THROUGH AND THOUGH SMALL BOWEL INJURY AND AN INJURY AT THE BASE OF THE SMALL BOWEL MESENTERY. THE LAPAROSCOPIC INSTRUMENTS AND PORTS WERE THEN WITHDRAWN AND CONVERSION TO OPEN LAPAROTOMY. THE SMALL BOWEL INJURY WAS REPAIRED USING INTERRUPTED ABSORBABLE SUTURES AND A VASCULAR SURGEON CALLED INTO THE THEATRE. THE VASCULAR INJURY WAS OVERSEEN WITH EXCELLENT HAEMOSTASIS APPROXIMATELY 700MLS OF BLOOD WAS LOST IN TOTAL. THE DECISION WAS THEN MADE TO PROCEED WITH AN OPEN COMPLETION OF THE INITIAL INTENDED HEMIFUNDOPLICATION." PATIENT STATUS: "ALIVE AND LIVING INDEPENDENTLY AT HOME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406107 KII 12X100 FIOS Z-THREADED GCJ GCJ APPLIED MEDICAL CTF73 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R