BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIFAST

    MDR report key: 6203720 · Received December 25, 2016

    Report

    Report Number
    9614654-2015-00012
    Event Type
    Malfunction
    Date Received
    December 25, 2016
    Date of Event
    July 6, 2015
    Report Date
    July 20, 2015
    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 US UNDER THIS DEVICE NAME, BUT IS IDENTICAL TO THE DEVICE "LACRIFLOW LACRIMAL STENT" DISTRIBUTED IN US UNDER 510(K) # K120886. - THE ACTUAL DEVICE USED WAS RETURNED AND INVESTIGATED:THE STAINLESS STEEL RING MOUNTED IN THE TIP OF THE COLORED IN BLUE TUBE WAS DISMOUNTED AND MISSING. THE OUTER/INNER DIAMETERS, LENGTH, AND ALL OTHER DIMENSIONS OF BOTH TUBES WERE CONFIRMED WITHIN THE SPECIFICATIONS. - THE DEVICE HISTORY RECORD (DHR) OF THE LACRIFAST WITH LOT NO. KP035046 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 WITH THE BOUGIE INSERTED FORCIBLY IN THE HEAVILY OCCLUDED LESION, 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 PENETRATION OF THE RING WITH THE BOUGIE OUT OF THE TUBE.

    Description of Event or Problem · 1

    THE DOCTOR INSERTED ONE OF THE LACRIMAL DUCT TUBE (COLORED IN BLUE) INTO THE OCCLUDED LACRIMAL DUCT WITH THE BOUGIE PROVIDED WITH THIS DEVICE INSERTING IN THE TUBE. THE DOCTOR FELT THAT THE BOUGIE PENETRATED OUT OF THE TUBE AND RETRIEVED IT OUT OF THE PATIENT'S LACRIMAL DUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853810 LACRIFAST LACRIMAL STENT OKS KANEKA CORPORATION KP035047

    Patients

    Seq Age Sex Outcome Treatment
    1 Other