BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIFAST

    MDR report key: 4009495 · Received July 17, 2014

    Report

    Report Number
    9614654-2014-00009
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 11, 2014
    Report Date
    July 17, 2014
    Manufacturer
    KANEKA CORPORATION
    Product Code
    OKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE "LACRIFAST" IS NOT DISTRIBUTED IN THE U.S. UNDER THIS DEVICE NAME, BUT IS IDENTICAL TO THE DEVICE "LACRIFLOW LACRIMAL STENT" DISTRIBUTED IN THE U.S. UNDER 510 (K) #K120886. THE ACTUAL DEVICE USED WAS RETURNED AND INVESTIGATED: BOTH STAINLESS STEEL RINGS MOUNTED IN THE COLORLESS TUBE AND THE BLUE-COLORED TUBE EACH WERE DROPPED OFF. THERE WERE 2 CAVES ON THE OUTER SURFACE OF THE COLORLESS TUBE WHERE THE RING WAS MOUNTED INSIDE. THERE WAS A HOLE PENETRATED THROUGH THE TUBE-WALL IN THE BLUE-COLORED ONE WHERE THE RING WAS MOUNTED. TO OUTER/INNER DIAMETERS, LENGTH AND ALL OTHER DIMENSIONS OF BOTH TUBES WERE CONFIRMED WITHIN THE SPECIFICATIONS. BOTH TUBES WERE CUT INTO HALF BY ITS LONGITUDINAL AXIS AND EACH CROSS SECTION WAS OBSERVED AND CONFIRMED THAT EACH OF THE RING HAD BEEN PROPERLY MOUNTED IN EACH TUBE. THE DEVICE HISTORY RECORD (DHR) OF THE LACRIFAST WITH LOT NO KP113451 WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN ITS MANUFACTURING PROCESSES. THE DEVICE MET ITS MATERIAL, ASSEMBLING AND PRODUCT SPECIFICATIONS. AS A POSSIBLE CAUSE OF THE PENETRATION OF THE BOUGIE AND DROPPING OFF THE RING DURING THE USE, WE SPECULATE AS FOLLOWS: WHEN THE DOCTOR TRIED TO INSERT AND ADVANCE THE TUBE FORCIBLY WITH THE BOUGIE INSERTED, EXCESSIVE MECHANICAL FORCE WAS LOADED ON THE RING AND THE DISTAL TIP OF THE TUBE WHERE THE RING WAS MOUNTED, AND FURTHER PUSHING THE BOUGIE RESULTED IN DISMOUNTING THE RING AND PENETRATING OUT OF THE TUBE WITH THE RING.

    Description of Event or Problem · 1

    WE GOT THE INFORMATION ABOUT THIS EVENT WHEN THE SALES REPRESENTATIVE IN CHARGE INTERVIEWED WITH THE DOCTOR. ACCORDING TO THE DOCTOR, HE TRIED TO INSERT AND PLACE THIS DEVICE, A LACRIMAL DUCT TUBE, "LACRIFAST", INTO THE PATIENT'S OCCLUDED LACRIMAL DUCT WITH THE BOUGIE PROVIDED WITH THIS DEVICE INSERTING IN THE DEVICE. HE FELT THAT THE BOUGIE PENETRATED OUT OF THE DEVICE. HE PULLED IT OUT OF THE PATIENT'S LACRIMAL DUCT AND FOUND THAT A STAINLESS STEEL RING MOUNTED IN THE DISTAL TIP OF THIS DEVICE WAS MISSING. A NEW LACRIMAL DUCT TUBE WAS PLACED IN THE LESION TO COMPLETE THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418945 LACRIFAST LACRIMAL STENT OKS KANEKA CORPORATION KP113451

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other