Holap (Holium Laser Resection/Vaporization) death report

Question to the people that have researched Holap or practice it. What
would cause death in a Holap procedure? The report is unclear.


COHERENT MEDICAL GROUP VERSAPULSE DUAL 80/100 SURGICAL LASERS back
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Catalog Number 0623-704-01
Event Date 10/03/2005
Event Type Death Patient Outcome Death; Required Intervention
Event Description
Customer requested service in 10/2005 to check proper operations of the
versapulse select unit. Customer biomedical engineering department
informed lumenis service in advance that a pt had expired due to a
surgical complication in association with a case performed with a
versapulse select. Lumenis field service evaluated the versapulse
select 5 days later and found the versapulse select, to be operating
within specification. Lumenis has requested from the hospital
additional information regarding the pt, procedure, cause of death and
laser fiber used.


Manufacturer Narrative
Lumenis service evaluated the customer's versapulse select laser and
found it to be within specification. Lumenis field service engineer
(fse) inquired about the laser fiber used in the suspect procedure;
lumenis fs was informed by hospital staff that the fiber used in the
case was probably thrown away. The fiber was stated by the hospital
staff to be a hblf-200, a 200 micron bare holmium laser. Fiber. The
hblf-200 fiber is not manufactured by lumenis, and lumenis does not
recomment the use of fibers manufactured by "third party" manufactures
for use with the lumenis versapulse select laser. Lumenis has requested
from the hospital a confirmation of which fiber (lumenis vs third
party) was used in the procedure in question. H6 no conclusion for
"results", as regards the fiber used at its interface with the laser,
can be drawn without the additional information requested from the
customer.



http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=640439

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