BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIFAST

    MDR report key: 6203737 · Received December 25, 2016

    Report

    Report Number
    9614654-2016-00016
    Event Type
    Malfunction
    Date Received
    December 25, 2016
    Date of Event
    May 27, 2016
    Report Date
    June 28, 2016
    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. ACCORDINGLY, THE MISSING STAINLESS STEEL RING MIGHT HAVE BEEN REMAINING IN THE PATIENT BODY. THE RING'S WHEREABOUTS WAS NOT CONFIRMED DURING THE PROCEDURE IN THIS EYE CLINIC; 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 OCCLUDED LACRIMAL DUCT, 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 BOUGIE WITH THE RING OUT OF THE TUBE.

    Description of Event or Problem · 1

    THIS DEVICE (LACRIFAST) WAS EMPLOYED TO TREAT THE EPIPHORA DUE TO LACRIMAL DUCT OBSTRUCTION OF (B)(6) PATIENT. THE DOCTOR INSERTED ONE OF THE LACRIMAL DUCT TUBE (COLORED IN BLUE) INTO THE LACRIMAL DUCT BY DSI (DIRECT SILICONE INTUBATION) TECHNIQUE. WHILE ADVANCING THE TUBE, THE DOCTOR FELT THAT THE BOUGIE PENETRATED OUT OF THE TUBE AND RETRIEVED IT OUT OF THE PATIENT'S LACRIMAL DUCT. HE USED ANOTHER LACRIFAST AND COMPLETED THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853719 LACRIFAST LACRIMAL STENT OKS KANEKA CORPORATION KP095197

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other