BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTF01, 5X150 KII FIOS ZTHR 6/BX

    MDR report key: 5791205 · Received July 13, 2016

    Report

    Report Number
    2027111-2016-00513
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    June 16, 2016
    Report Date
    December 9, 2016
    Manufacturer
    AMR
    Product Code
    GCJ
    PMA / PMN Number
    K041795
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE 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.

    Additional Manufacturer Narrative · 1

    HOSPITAL DOES NOT HAVE THE PRODUCT TO RETURN AS OF 03OCT2016 THE EVENT PRODUCT WAS NOT RETURNED FOR EVALUATION. ENGINEERING REVIEWED AN IMAGE PROVIDED BY THE COMPLAINANT; HOWEVER, IT DID NOT SHOW ANY VISIBLE NON-CONFORMANCES. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT, A REVIEW OF THE MANUFACTURING RECORDS FOR THE LAST SIX (6) LOTS PURCHASED BY THE COMPLAINANT SHOWED THAT THE PRODUCT MET ALL MANUFACTURING AND QUALITY STANDARDS. DURING THE MANUFACTURING PROCESS, ALL TROCARS ARE THOROUGHLY INSPECTED FOR FUNCTIONALITY AND PERFORMANCE PRIOR TO PACKAGING. THE 5MM SPARTAN DUCKBILL, FOUND IN THE SEAL OF THE OBTURATOR, UNDERGOES A MANUFACTURING PROCESS CALLED CHLORINATION WHICH REDUCES THE FRICTION BETWEEN THE RUBBER COMPONENTS AND INSTRUMENTS. THE ROOT CAUSE COULD NOT BE CONFIRMED BECAUSE THE EVENT UNIT WAS NOT RETURNED; HOWEVER, IT IS POSSIBLE THAT THERE WAS SURFACE FRICTION BETWEEN THE SCOPE AND THE SPARTAN DUCKBILL. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. IN ACCORDANCE WITH 21 CFR 803.56, IF ADDITIONAL INFORMATION IS OBTAINED WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    ROBOTIC GASTRIC SLEEVE - "ISSUE HAPPENED DURING INITIAL INSERTION. SURGEON WENT IN OPTICALLY AND COULD NOT REMOVE SCOPE FROM THE OBTURATOR. THEY HAD TO APPLY AN EXTREME AMOUNT OF FORCE TO TAKE WHOLE OBTURATOR OUT WITH THE SCOPE." TYPE OF INTERVENTION - "N/A." PATIENT STATUS - "STABLE FINE."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED VIA E-MAIL JULY 13, 2016 FROM AN APPLIED MEDICAL REPRESENTATIVE:"I DON'T KNOW THE ALCOHOL USED [TO CLEAN THE SCOPE], BUT IT WAS ONLY HAPPENING WITH STRYKER CAMERAS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444626 CTF01, 5X150 KII FIOS ZTHR 6/BX GCJ GCJ AMR CTF01 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1