BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRIFAST

    MDR report key: 6515164 · Received April 24, 2017

    Report

    Report Number
    9614654-2017-00005
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    April 10, 2017
    Report Date
    April 10, 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 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 NOT RETURNED. 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. - THE DEVICE HISTORY RECORD (DHR) OF THE LACRIFAST WITH LOT NO. KP126196 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 DROPPING OFF THE STAINLESS STEEL RING DURING THE USE, WE SPECULATE AS FOLLOWS: WHEN THE DOCTOR TRIED TO DECANNULATE THE SHEATH TO PLACE THIS DEVICE IN THE PATIENT'S LACRIMAL DUCT BY THE G-SGI TECHNIQUE, AN EXCESSIVE MECHANICAL FORCE WAS LOADED TO THE RING MOUNTED PORTION, AND THE RING WITH THE BOUGIE PENETRATED OUT OF 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 OF A FEMALE PATIENT. THE DOCTOR PRE-OPENED THE LACRIMAL DUCT BY USING A SHEATH. THEN, HE INSERTED ONE OF THE PAIR OF LACRIMAL DUCT TUBES INTO THE SHEATH, THAT WAS PRE-INSERTED IN THE LACRIMAL DUCT, BY USING THE G-SGI (GOTO-SHEATH GUIDED INTUBATION) TECHNIQUE. WHILE DECANNULATING THE SHEATH FROM THE LACRIMAL DUCT, HE FELT A STRONG RESISTANCE. HE RETRIEVED THE SHEATH AND LACRIFAST OUT OF THE PATIENT'S LACRIMAL DUCT, AND FOUND THE STAINLESS STEEL RING MOUNTED IN THE TIP OF THE TUBE WAS MISSING. HE USED ANOTHER LACRIFAST TO COMPLETE THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298390 LACRIFAST LACRIMAL STENT OKS KANEKA CORPORATION KP126196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other