BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIFAST

    MDR report key: 6203738 · Received December 25, 2016

    Report

    Report Number
    9614654-2016-00017
    Event Type
    Malfunction
    Date Received
    December 25, 2016
    Date of Event
    July 19, 2016
    Report Date
    July 21, 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 CLEAR 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, WE SPECULATE AS FOLLOWS: WHEN THE DOCTOR ATTEMPTED TO PULL OFF THE SHEATH ALONE FORCIBLY OVER THE TUBE PLACED IN THE LESION, EXCESSIVE FORCE WAS LOADED ON THE RING AND IT RESULTED IN THE BOUGIE'S PENETRATING OUT OF THE TUBE WITH THE RING. THIS REPORT IS DELAYED BECAUSE IT WAS SENT TO THE EMDR TEST INSTEAD OF PRODUCTION.

    Description of Event or Problem · 1

    THIS DEVICE (LACRIFAST) WAS EMPLOYED TO TREAT THE EPIPHORA DUE TO LACRIMAL DUCT OBSTRUCTION OF (B)(6) FEMALE PATIENT. THE DOCTOR PRE-OPENED THE LACRIMAL DUCT BY USING A DACRYOENDOSCOPY AND A SHEATH. THEN, HE TRIED TO INSERT ONE OF THE PAIR OF LACRIMAL DUCT TUBES (COLORED IN CLEAR) INTO THE SHEATH, THAT WAS PRE-INSERTED IN THE LACRIMAL DUCT, BY USING THE G-SGI (GOTO-SHEATH GUIDED INTUBATION) TECHNIQUE. WHILE ADVANCING THE TUBE WITH THE BOUGIE INTO THE SHEATH PLACED IN THE LACRIMAL DUCT, HE FELT A STRONG RESISTANCE AND THAT THE BOUGIE PENETRATED OUT OF THE TUBE. HE RETRIEVED IT OUT OF THE PATIENT'S LACRIMAL DUCT, AND USED ANOTHER LACRIFAST TO COMPLETE THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853724 LACRIFAST LACRIMAL STENT OKS KANEKA CORPORATION KP026310

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other