BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTR73 12X100 KII OPT ZTHR 6/BX

    MDR report key: 5804315 · Received July 19, 2016

    Report

    Report Number
    2027111-2016-00529
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    May 11, 2016
    Report Date
    June 21, 2016
    Manufacturer
    AMR
    Product Code
    GCJ
    UDI-DI
    00607915123680
    PMA / PMN Number
    K060096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER AND PROVIDED. INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING CONFIRMED THE TIP OF THE CANNULA WAS FRACTURED. DURING THE MANUFACTURING PROCESS, ALL TROCARS ARE THOROUGHLY INSPECTED FOR FUNCTIONALITY AND PERFORMANCE PRIOR TO PACKAGING. THE ROOT CAUSE OF THIS INCIDENT IS LIKELY DUE TO MANUFACTURING. APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE DEVICE ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO OCCUR. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS. 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.

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS 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

    ADDITIONAL INFORMATION RECEIVED VIA E-MAIL FROM AN APPLIED MEDICAL TEAM MEMBER ON (B)(6) 2016: THIS SURGEON USES CTR73 TROCAR TO INSERT THE 1ST ACCESS, USING THE HASSON TECHNIQUE; SO, IN ORDER TO AVOID ANY PROBLEM WITH THE SEPARATOR TIP/SEQUENTIAL HELIX DURING THE INSERTION, HE INSERT A METALLIC STAKE WITH BLUNT TIP. THE WHOLE HOSPITAL USES APPLIED'S TROCARS (Z-THREAD, BLUNT TIP AND ADVANCED FIXATION). THE DEFECT WAS FIRST NOTICED DURING THE FIRST PART OF THE PROCEDURE, WHEN THEY HAVE INSERTED THE SCOPE TO EXAMINE THE ABDOMEN.

    Description of Event or Problem · 1

    LAPAROSCOPIC APPENDECTOMY- "DURING USE WITH SCOPE, A DEFECT WAS NOTICED AT CANNULA TIP (IT WASN'T PERFECTLY ROUNDED). AFTER TAKING OFF THE CANNULA, IT WAS NOTICED THAT SUCH DEFECT WAS DUE TO A CRACK ON CANNULA TIP. BY TOUCHING IT, A PLASTIC PIECE DETACHED. TROCAR WAS SUBSTITUTED WITH ANOTHER ONE, SAME MODEL, THAT GAVE NO ANY PROBLEM (SPEAKING WITH OR WE LEARNED THEY USE TO INSERT OUR CANNULA (AS FIRST TROCAR) NOT WITH ITS OWN OBTURATOR, BUT WITH A SORT OF BLUNT TIP OBTURATOR. NO INFO ON THIS OBTURATOR DIAMETER) EVENT WAS REPORTED TO ITALIAN MINISTRY OF HEALTH AS "POTENTIAL INCIDENT." PATIENT STATUS- 'PATIENT STATUS WAS GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459052 CTR73 12X100 KII OPT ZTHR 6/BX GCJ GCJ AMR CTR73 1259362 00607915123680

    Patients

    Seq Age Sex Outcome Treatment
    1