BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACRIFAST

    MDR report key: 11918460 · Received June 2, 2021

    Report

    Report Number
    3009761573-2021-00001
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    April 13, 2021
    Report Date
    April 21, 2021
    Manufacturer
    KANEKA CORPORATION
    Product Code
    OKS
    UDI-DI
    04540778140875
    PMA / PMN Number
    K120886
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE USED WAS RETURNED AND INVESTIGATED: THERE WAS A HOLE, FROM WHERE THE BOUGIE WAS THOUGHT TO PENETRATE OUT,IN THE DISTAL TIP OF THE TUBE (COLORED IN CLEAR) WHERE A STAINLESS STEEL RING WAS MOUNTED, AND THE RING WAS DISMOUNTED AND MISSING. THE RING'S WHEREABOUTS WAS NOT CONFIRMED DURING THE PROCEDURE IN THIS EYE CLINIC, AND ACCORDINGLY, IT HAS A POSSIBILITY THAT THE MISSING STAINLESS STEEL RING MIGHT HAVE BEEN REMAINING IN THE PATIENT BODY. 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

    THE DOCTOR FELT THE BOUGIE PIERCED THROUGH THE TUBE AS HE ADVANCED THE LACRIMAL TUBE. SHE RECOVERED THE LACRIMAL TUBE FROM THE PATIENT'S LACRIMAL DUCT AND FOUND THAT SHE HAD A HOLE. 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, IT HAS A POSSIBILITY THAT THE MISSING STAINLESS STEEL RING MIGHT HAVE BEEN REMAINING IN THE PATIENT BODY. THIS DEVICE IS THE SAME DEVICE AS THE US NAME LACRIFLOW (510 (K) # K120886).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817153 LACRIFAST LACRIMAL STENTS AND INTUBATION SETS OKS KANEKA CORPORATION LF-R090A KP099084 04540778140875

    Patients

    Seq Age Sex Outcome Treatment
    1 Other