ALFONZO EYE SPECULUM NEWBORN

Description of Event or Problem

OPHTHALMOLOGIST USED SPECULUM DURING ROUTINE EYE EXAM ON NEWBORN. AFTER COMPLETING THE EXAM; UPON REMOVAL OF THE SPECULUM FROM THE EYE, PHYSICIAN OBSERVED THAT A PORTION OF THE SPECULUM HAD BROKEN OFF LEAVING A SHARP EDGE. AN X-RAY WAS OBTAINED TO RULE OUT A PIECE OF SPECULUM LODGING IN THE EYE. X-RAY NEGATIVE. EYE EXAM CONDUCTED TO RULE OUT ANY INJURY FROM BROKEN SPECULUM. EYE EXAM NORMAL. MANUFACTURER RESPONSE (AS PER REPORTER) FOR SPECULUM, OPTHALMIC, OPHTHALMIC SPECULUM (ITEM #615W411200-00).THEY SOLD OVER 800 SPECULUMS WITHOUT REPORT OF BREAKAGE. CONCEDED THAT BREAKAGE WOULD DEPEND ON THE CARE AND HANDLING OF THE SPECULUM.