BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII 5X100 Z-THR CANNULA / SEAL 12/BOX

    MDR report key: 4090698 · Received September 15, 2014

    Report

    Report Number
    2027111-2014-00336
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 8, 2014
    Report Date
    November 6, 2014
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K060096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING FOUND THE TIP OF THE CANNULA WAS FRACTURED AND THE UNIT WAS MISSING A PORTION OF THE TIP. NO OTHER DAMAGES WERE FOUND. DURING THE MANUFACTURING PROCESS, ALL KII TROCARS ARE THOROUGHLY INSPECTED AND TESTED FOR FUNCTIONALITY AND PERFORMANCE PRIOR TO PACKAGING. ENGINEERING WAS UNABLE TO CONFIRM THE ROOT CAUSE OF THIS INCIDENT; HOWEVER, THE FRACTURED TIP MAY HAVE BEEN CAUSED BY APPLYING CONSTANT FORCE TO THE CANNULA WITH A SURGICAL DEVICE OR OVER-TORQUING THE CANNULA. THE INSTRUCTIONS FOR USE (IFU) WARNS THAT EXTRA CARE SHOULD BE USED WHEN INSERTING ANGULAR AND ASYMMETRICAL INSTRUMENTS, SUCH AS "J" HOOKS AND CLIP APPLIERS. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT 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 CHOLE - "MISSING PORTION OF LOWER CANNULA TIP: STAFF FIRST NOTICED AT END OF PROCEDURE WHEN REMOVING TROCAR THAT A SMALL PIECE OF PLASTIC WAS MISSING FROM END OF CANNULA. A SEARCH WAS MADE IN ABDOMEN FOR MISSING PIECE OF PLASTIC, HOWEVER ABDOMEN WAS ALL CLEAR."INTERVENTION - "SEARCH IN ABDOMEN WAS PERFORMED - NIL FOUND."PATIENT STATUS - "NORMAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570159 KII 5X100 Z-THR CANNULA / SEAL 12/BOX GCJ GCJ APPLIED MEDICAL CTS02 1212126

    Patients

    Seq Age Sex Outcome Treatment
    1