BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIFAST

    MDR report key: 6203724 · Received December 25, 2016

    Report

    Report Number
    9614654-2016-00003
    Event Type
    Malfunction
    Date Received
    December 25, 2016
    Date of Event
    January 23, 2016
    Report Date
    January 27, 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 DISTAL TIP OF THE TUBE (COLORED IN BLUE) WAS TORN OFF AND THE STAINLESS STEEL RING MOUNTED THERE WAS MISSING. WE OBSERVED THE TUBE TORN OFF SURFACE; THERE WERE A STREAKY-PATTERNED PORTION AND REMAINED PORTION WITH TEXTURED-PATTERN. THE STREAKY-PATTERNED IS CHARACTERISTIC FOR THE SURFACE CUT DOWN BY A SHARP-BLADE LIKE A PAIR OF SCISSORS, AND THE TEXTURED-PATTERNED IS CHARACTERISTIC FOR THAT TORN OFF BY STRONG TENSILE-FORCE. FROM THE ABOVE INVESTIGATION RESULTS, WE SPECULATE THAT THE TUBE WAS INJURED BY SOMETHING LIKE A SHARP-BLADE DURING THE PROCEDURE AND RESULTED IN TORN OFF OF THE DISTAL TIP BY A STRONG TENSILE FORTH WHILE PULLING OUT THE SHEATH. THIS REPORT IS DELAYED BECAUSE IT WAS SENT TO THE EMDR TEST INSTEAD OF PRODUCTION.

    Description of Event or Problem · 1

    THE DOCTOR TRIED TO INSERT ONE OF THE PAIR OF LACRIMAL DUCT TUBES (COLORED IN BLUE) INTO THE LACRIMAL DUCT BY THE SGI (SHEATH GUIDED INTUBATION) TECHNIQUE. THE TUBE WAS INSERTED THROUGH THE LACRIMAL PUNCTUM INTO THE SHEATH PLACED IN THE LACRIMAL DUCT, AND THE SHEATH WAS PULLED OUT FROM THE NASAL CAVITY TO REMAIN THE TUBE IN THE LACRIMAL DUCT. AFTER THE INTUBATION, SHE CHECKED THE TUBE POSITION AND FOUND THE DISTAL TIP OF THE TUBE WITH THE STAINLESS STEEL RING WAS MISSING. SHE TRIED BUT FAILED TO FIND THE TORN OFF TIP OF THE TUBE AND THE RING IN THE LACRIMAL DUCT BY USING A DACRYOENDOSCOPY, SHE USED A NEW SAME PRODUCT AND COMPLETED THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853730 LACRIFAST LACRIMAL STENT OKS KANEKA CORPORATION KP085265

    Patients

    Seq Age Sex Outcome Treatment
    1 Other