Greenlight XPS - Gastroenterology Complications; Gynecology Complications; Head and Neck;Otorhinolaryngology (ENT) Complications; Neurosurgery Complications

Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
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Perforation: Perforation can occur as a result of excessive exposure to laser radiation. Perforation can occur from tumor erosion, or as a result
ofendoscopic/cystoscopicprocedure.Toclinicallydiagnoseperforations,patientsmustbecloselymonitoredpost-operativelythroughphysical
assessment of clinical symptoms, hematology studies as deemed appropriate, and radiography.
Sepsis: Laser-ablated tissue may become infected after therapy. If a question of sepsis exists, a culture should be taken and other appropriate
evaluations made.
As with conventional endoscopic treatments, adverse reactions such as fever, chills, sepsis, edema, and hemorrhage are possible after laser
treatment. In extreme cases, death may occur due to procedural complications, concurrent illness, or the application of the laser. Use caution
when treating patients who had difficulty with previous endoscopic procedures.
6.2 Complications And Risks By Indication
Forallindications,seeIntendedUse/IndicationsforUsesection.
General Surgery
Complications and Risks: See Adverse Events for general information. There is a potential risk of thermal damage at the site of the incision.
Forendoscopic/laparoscopicprocedures,therearenoknowncomplicationsandrisksspecifictogeneralsurgeryotherthanthoseassociatedwith
laparoscopy procedures in general (that is, over-distension, subcutaneous emphysema).
See Contraindications for general information. There are no known contraindications specific to general surgery at this time. Endoscopic/
laparoscopic procedure patients should be treated with alternative methods when laparoscopy is contraindicated.
Gastroenterology
See Adverse Events for general information.
The risk of combustion, perforation and laser-induced hemorrhage, all of which could cause serious or fatal complications, must be fully explained
to the patients.
Use caution when radiation therapy and laser therapy are to be used concurrently, including more stringent post-operative monitoring. Patients
who have undergone radiation therapy may present a greater risk of perforation or tissue erosion. Use caution with patients who had previous
esophageal/trachealfistulaeorepisodesofaspiration.
Discontinuelasertherapyimmediatelyifthepatientdevelopscardiopulmonaryproblems.
To avoid the potential risk of endoscope ignition or damage from the treatment beam or treatment beam backscatter, it is recommended that the
fiber extend 1 to 2 cm beyond the distal port of the endoscope, so it is entirely in the visual field.
After esophageal procedures, swallowing may be paradoxically worsened, rather than immediately improved. This is caused by secondary tissue
edema. Explain this potential problem to the patient before therapy.
See Contraindications for general information. There are no known contraindications specific to gastroenterological use at this time.
Gynecology
See Adverse Events for general information. There are no known complications and risks specific to gynecology at this time.
See Contraindications for general information. These procedures may be contraindicated for women who are pregnant or have a suspected
pregnancy, and for whom hysteroscopy or laparoscopy, or open abdominal surgery would not be appropriate. These procedures may be
contraindicated for women with other medical or surgical conditions that would contraindicate laparoscopic or hysteroscopic surgery.
Head and Neck/Otorhinolaryngology (ENT)
See Adverse Events for general information. For cosmetic purposes, it is recommended that initial incisions be performed with conventional
scalpels or that skin edges incised with the laser be cut back by approximately 0.5 mm to 1.0 mm with a scalpel before closing the skin.
Use caution to protect the endotracheal tubes. Contact with the laser beam could result in serious or fatal patient complications. When using the
laser for coagulation in ENT applications, it is essential to de-focus the laser beam spot to preclude tissue damage beyond the desired coagulation
site. Unintended tissue damage could result from a focused treatment beam. While clinical experience to date has demonstrated that lasers can
be safely used for hemostatic in ENT, there have been reports of serious complications when lasers are used inappropriately.
The main risk of laser use is thermal damage to the surrounding vital structures, which is risky for oval window surgery as energy applied directly to the
open oval window will pass directly through the perilymph and be absorbed by the inner ear structures. Other complications related to laser surgery
include, but are not limited to burns, scarring, hemorrhage, perforations, fires and explosions, eye injury, electrical shock, swelling, and obstruction.
Thermal damage caused by laser treatment has been related to adverse side effects and other risks. For example, where laser tissue welding
isused,suchasinlaser-assistedmyringoplasty,alowstrengthanastomosisorthermaldamagetotissuearethemainconcerns.Delayedpost-
operative pain and slow healing are both thought to be related to thermal damage caused by the laser during tonsillectomy.
Compared to traditional scalpel cutting surgery, laser treatment has sometimes resulted in slower healing in procedures such as uvulopalatoplasty
and tonsillectomy. Tissue necrosis, post-operative edema, or bleeding was rarely seen. Slow healing increases the risk of infection. The presence
of necrosis could leave the tonsillar bed more vulnerable to infection.
See Contraindications for general information. There are no known contraindications unique to ENT.
Neurosurgery
Particular care must be exercised in heating the brain stem area. Flushing with cool saline in such areas will reduce heat build-up and related bradycardia.
See Adverse Events for general information. There are no known specific complications and risks to neurosurgery use at this time.
See Contraindications for general information. These procedures are contraindicated for the treatment of necrotic or calcified tumors.
Ophthalmology
See Adverse Events for general information. There are no known specific complications and risks to ophthalmology use at this time.
See Contraindications for general information. These procedures are contraindicated for the treatment of necrotic or calcified tumors.