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Patient 1
THE DOCTOR PROVIDED A VIDEO OF THE PROCEDURE WHERE A PIECE OF THE LASER PROBE BECAME DETACHED. THE VIDEO SHOWS THE LASER EXTENDED IN THE EYE AND THE LASER NOT GETTING MUCH UPTAKE. THE LASER WAS RETRACTED AND THE FOCUS GETS A LITTLE FUZZY THEN THERE WAS A SMALL BROWN LINE NEAR THE MACULA. THE DOCTOR USED A SOFT TIP CANNULA TO PULL IT OUT AND IT IS CLEARER OUTSIDE THE EYE. THE COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION IN A BIOHAZARD BAG ON (B)(6) 2017. THE PORTION OF THE PROBE WHICH BROKE WAS THE FRONT (DISTAL) END OF THE FIBER; APPROXIMATELY 3/32? IN LENGTH. IT WAS EXAMINED UNDER MAGNIFICATION WHILE IN THE BAG. THE POLISHED END OF THE FIBER (DISTAL END) WAS VISIBLE WITH NO DAMAGE EVIDENT WHILE THE OTHER END WAS VISIBLY BLACKENED. THERE WAS NO FIBER VISIBLE UNDER MAGNIFICATION IN THE NITINOL TUBE, SUGGESTING THAT THE CRACK OR BREAK IN THE FIBER OCCURRED INSIDE THE METAL NITINOL TUBE. VALUE STREAM MANUFACTURING ENGINEER, VALUE STREAM LINE SUPERVISOR AND QA REVIEWED THIS PIECE UNDER 22X MAGNIFICATION DURING A (B)(6) 2017 MEETING AND INDICATED THAT THEY HAD NOT PREVIOUSLY SEEN A BREAK PATTERN LIKE THIS ONE ON THE 150-MICRON FIBER DESIGN; THE PREVIOUS 200-MICRON FIBER DESIGN WAS MORE RIGID AND DID HAVE A BREAKAGE ISSUE. THIS IS CONSIDERED AN ISOLATED INCIDENT.