BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCJ

    MDR report key: 5216036 · Received November 10, 2015

    Report

    Report Number
    2027111-2015-00783
    Event Type
    Malfunction
    Date Received
    November 10, 2015
    Date of Event
    October 6, 2015
    Report Date
    October 8, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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

    ADDITIONAL INFORMATION WAS REQUESTED AND NOT PROVIDED. COMPLETE UDI NUMBER UNABLE TO BE PROVIDE AS NO MODEL NUMBER OR LOT NUMBER COULD NOT BE CONFIRMED. SALES REP CONFIRMED THAT THERE IS NO WAY OF FINDING OUT EXACTLY WHAT SPECIFIC PRODUCT/LOT WAS USED. INVESTIGATION SUMMARY: THE INCIDENT PRODUCT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. DURING THE MANUFACTURING PROCESS, ALL TROCARS ARE THOROUGHLY INSPECTED FOR FUNCTIONALITY AND PERFORMANCE PRIOR TO PACKAGING. 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. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED UNKNOWN. "REPORT FROM HOSPITAL READS AS FOLLOWS...'REPEATED PROBLEM WITH APPLIED MEDICAL PORTS SLIPPING OUT. THIS REQUIRED MULTIPLE RE-INSERTIONS (PROBABLY APPROX 12 TIMES) SO MULTIPLE TRACTS CREATED. GAS LEAKING FROM PORT RESULTED IN GROSS SURGICAL EMPHYSEMA. PATIENT BECAME PROFOUND ACIDOTIC. THE MULTIPLE RE-INSERTIONS OF THE PORT ALSO CAUSED UNNECESSARY SOFT TISSUE TRAUMA AND BLEEDING.' I WAS NOT IN THE OPERATION TO OBSERVE ACTUAL EVENTS. PRODUCT REGULARLY ORDERED BY THIS ACCOUNT ARE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743444 GCJ GCJ APPLIED MEDICAL TBD TBD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other