BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CFR03, 5X100 KII OPT ADVFIX 6/BX

    MDR report key: 4537282 · Received February 23, 2015

    Report

    Report Number
    2027111-2015-00043
    Event Type
    Malfunction
    Date Received
    February 23, 2015
    Date of Event
    December 23, 2014
    Report Date
    July 27, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K083638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# 1222799 UPON PRODUCT RETURNED. INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING INFLATED THE BALLOON, AND THE BALLOON REMAINED INFLATED. THE DEVICE WAS THEN SUBMERGED UNDERWATER, AND NO BUBBLES FORMED FROM THE BALLOON OR BALLOON INFLATION PORT. ENGINEERING NOTED SCRATCHES IN THE TUBING NEAR THE AIR DOME; HOWEVER THIS WAS A COSMETIC ISSUE AND DID NOT CAUSE LEAKAGE. A REVIEW OF THE MANUFACTURING RECORDS INDICATES THIS LOT PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS. ALTHOUGH THE UNIT MET CURRENT SPECIFICATIONS DURING THE EVALUATION OF THE DEVICE, THE TEAM WILL CONTINUE TO INVESTIGATE AND MONITOR THIS TYPE OF INCIDENT. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS CONTINUOUS PROCESS, ENGINEERING IS CURRENTLY RESEARCHING DEVICE IMPROVEMENTS TO FURTHER PREVENT THIS TYPE OF INCIDENT FROM OCCURRING. THIS DOCUMENT REPRESENTS OUR FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS TO FOLLOW UP WITH MEDWATCH# 2600320000-2014-8107. 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

    "DURING LAPAROSCOPIC CHOLECYSTECTOMY BALLOON ON TROCAR WOULD NOT DEFLATE WHEN A SYRINGE WAS USED. THIS WAS ATTEMPTED SEVERAL TIMES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126914 CFR03, 5X100 KII OPT ADVFIX 6/BX GCJ GCJ APPLIED MEDICAL CFR03 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1