BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIFAST

    MDR report key: 6986216 · Received October 29, 2017

    Report

    Report Number
    3009761573-2017-00004
    Event Type
    Malfunction
    Date Received
    October 29, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 17, 2017
    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 US UNDER THIS DEVICE NAME, BUT IS IDENTICAL TO THE DEVICE "LACRIFLOW LACRIMAL STENT" DISTRIBUTED IN THE US UNDER 510(K) # K120886. - THE ACTUAL DEVICE USED WAS RETURNED AND INVESTIGATED: NO DEFORMATION OR DAMAGE WAS FOUND IN THE PAIR OF TUBES EXCEPT FOR MISSING THE STAINLESS-STEEL RING MOUNTED IN THE TIP OF THE TUBE (COLORED IN CLEAR). - 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 IN THE TUBE FORCIBLY IN THE OCCLUDED NASAL DUCT, EXCESSIVE MECHANICAL FORCE WAS LOADED ON THE RING, WHERE THE TIP OF THE BOUGIE TOUCHED, AND THE BOUGIE TOGETHER WITH THE RING PENETRATED OUT OF THE OPENING DUCT IN THE TIP OF THE TUBE.

    Description of Event or Problem · 1

    THIS DEVICE (LACRIFAST) WAS EMPLOYED TO TREAT THE EPIPHORA DUE TO LACRIMAL DUCT OBSTRUCTION. THE DOCTOR INSERTED ONE OF THE LACRIMAL DUCT TUBE (COLORED IN CLEAR) INTO THE OBSTRUCTED LACRIMAL DUCT. WHILE ADVANCING THE TUBE, THE DOCTOR FELT STRONG RESISTANCE AND GAVE UP TO FURTHER INSERT THE TUBE, AND HE RETRIEVED IT OUT OF THE PATIENT'S LACRIMAL DUCT. WHEN THE ACTUAL DEVICE USED WAS INVESTIGATED, THE RING WAS DISMOUNTED AND MISSING. THE RING'S WHEREABOUTS WAS NOT CONFIRMED DURING THE PROCEDURE IN THIS EYE CLINIC, AND ACCORDINGLY, THE MISSING STAINLESS STEEL RING MIGHT HAVE BEEN REMAINING IN THE PATIENT BODY. HE USED ANOTHER LACRIFAST AND COMPLETED THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765573 LACRIFAST LACRIMAL STENT OKS KANEKA CORPORATION KP047292

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other