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.
D
Patient 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.