http://usaeyes.us/news-stories/dr.-james-loden-fails-to-service-microkeratome-for-3-years.html
http://tinyurl.com/6z8cc4
Model Number MK-2000
Device Problems Stops intermittently; Other (for use when an appropriate
device code cannot be identified); Damage, internal/external
Event Date 03/27/2008
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
The following is a description of the event as relayed to nidek inc both
verbally and on the mk complaint form by loden vision center: in 2008, the
physician was creating a tem****al incision on the pt's mayopic right eye,
with the mk-2000 hand piece, 180um blade holder and the 9. 0mm suction
ring
combination. The microkeratome was placed on the cornea, good suction
obtained and noted. Keratome "bucked" and stopped. Physician stated
"keratome appeared to have jammed into the lid speculum. " the
microkeratome
was removed from the pt's eye and reinspected, proper assembly confirmed,
wedge in place and full test run performed. "all appeared normal. "
suction
ring was placed back on the cornea and suction acquired. Microkeratome
advanced and immediately stopped when suction was lost. Microkeratome was
removed from the pt's eye. "anterior chamber noted to be flat, but
anatomically intact. " "anterior chamber filled with viscoat as large
opening tem****aily where keratome entered the eye. " a bandage contact
lens
was placed and pt was given vigamox. Patient was trans****ted to the
operating room and the cornea was sutured. The following month, dr's
handpiece and blade holder were received at nidek inc. For inspection.
Prior
to the inspection, it was found that this microkeratome had not been
serviced for 3 years. During the inspection, the technician found the hand
piece ot be out of specification and the blade holder had damage on the
surface. It is nidek's conclusion that the problems found with the
microkeratome did not attribute to the incident of the perforated cornea.
It
has been determined as user error.
Event Description
On 03/31/08, nidek inc rec'd re****t of an adverse event from facility. Rep
re****ted that while using the mk-2000, the patients anterior chamber of
the
right cornea was perforated, on the tem****al side of the eye. Rep stated,
that the perforation was not near the visual axis and that the pt's vision
was not affected. The pt required 3 sutures on the cornea. Dr loden stated
that during the procedure the mk-2000 (keratome) may have come in contact
with the lid speculum while creating the corneal flap causing the keratome
to "dive" into the eye.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1032770
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