BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 5741250 · Received June 22, 2016

    Report

    Report Number
    1037955-2016-00016
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Date of Event
    May 24, 2016
    Report Date
    June 6, 2016
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K121938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE FIBER REVEALED A CREASE IN THE BLUE TUBING APPROXIMATELY 2 INCHES FROM THE STRAIN RELIEF BOOT AT THE PROXIMAL END OF THE FIBER. WHEN THE FIBER WAS CONNECTED TO A TEST LASER, LIGHT WAS EMITTED FROM THE AREA WHERE THE CREASE WAS OBSERVED WHILE NO LIGHT WAS DETECTED AT THE DISTAL TIP OF THE FIBER. THESE SYMPTOMS INDICATE THAT THERE IS A BREAK IN THE FIBER AT THE OBSERVED CREASE IN THE BLUE TUBING. ANOTHER FIBER OF THE SAME PART NUMBER (K2013151), BUT DIFFERENT LOT NUMBER (F1716R) WAS PULLED FROM FIBER OVERAGE FOR ADDITIONAL TESTING. A BREAK OF THE SAME TYPE AND LOCATION WAS ABLE TO BE REPLICATED WITH THE TEST FIBER WHEN THE FIBER WAS REMOVED AT AN OUTWARD ANGLE FROM THE PLASTIC TUBING PACKAGING. IT IS LIKELY THAT WHEN THE CUSTOMER REMOVED THE COMPLAINT FIBER FROM THE PLASTIC TUBING PACKAGING, THEY ACCIDENTLY BENT THE FIBER AT AN OUTWARD ANGLE LEADING TO THE "DENT" AND SUBSEQUENT BREAK NOTED IN THE FIBER. IT IS LIKELY THAT THE BREAK HAPPENED SOMETIME AFTER INITIAL CUSTOMER USE SINCE ALL FIBERS ARE FUNCTIONALLY TESTED DURING MANUFACTURING WHICH INCLUDES RFID TAG PROGRAMMING AND TESTING, AND QC INSPECTION DURING PACKAGING ACTIVITIES. IT CAN BE ASSUMED THAT DURING EVALUATION TESTING THAT IT IS VERY UNLIKELY THERE WERE ANY MANUFACTURING FAULTS WITH THE FIBER.

    Description of Event or Problem · 1

    WHEN A NEW 270 MICRON FIBER WAS USED, IT DIDN'T WORK PROPERLY. THERE WAS A DENT IN THE FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397216 DORNIER HOLMIUM LASER FIBER HOLMIUM FIBER GEX DORNIER MEDTECH AMERICA, INC. 270 UM REUSABLE RFID F1216R

    Patients

    Seq Age Sex Outcome Treatment
    1