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Patient 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. THE OUTER/INNER DIAMETERS, LENGTH, AND ALL OTHER DIMENSIONS OF BOTH TUBES WERE CONFIRMED WITHIN THE SPECIFICATIONS. - THE DEVICE HISTORY RECORD (DHR) OF THE LACRIFAST WITH LOT NO. KP035046 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 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 HEAVILY OCCLUDED LESION, 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 RING WITH THE BOUGIE OUT OF THE TUBE. THIS REPORT IS DELAYED BECAUSE IT WAS SENT TO THE EMDR TEST INSTEAD OF PRODUCTION.