BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIFAST

    MDR report key: 4020925 · Received August 19, 2014

    Report

    Report Number
    9614654-2014-00010
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 30, 2014
    Manufacturer
    KANEKA CORP.
    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 COLORLESS TUBE WAS DROPPED OFF. THERE WAS A HOLE PENETRATED THROUGH THE TUBE-WALL IN THE COLORLESS ONE WHERE THE RING WAS MOUNTED. 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. KP014158 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

    THE DOCTOR 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496988 LACRIFAST LACRIMAL STENT OKS KANEKA CORP. KP014158

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other