Greenlight XPS - Precautions; Adverse Events; Abdominal Bloating (Intestinal Gas); Acute Renal Failure

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
5
• Theriskofcombustion,perforation,andlaser-inducedhemorrhage,allofwhichcouldcauseseriousorfatalcomplications,mustbefully
explained to the patient.
• Aswithnon-lasertreatments,adversereactionssuchasfever,chills,sepsis,edema,andhemorrhagemayoccurafterlasertreatment.In
extreme cases, death may occur due to procedural complications, concurrent illness, or the application of the laser.
• Cautionshouldbetaken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.
• Usecautionwhentreatingpatientswhohaddifficultywithpreviousendoscopic/cystoscopicprocedures.
• Noclaimismadethatthelasersystemwillcurethemedicalconditionoreliminatethediseasedentity.Repeatedtreatmentoralternative
therapies may be required.
• BSChasnoclinicalinformationorexperienceconcerningtheuseofthelasersystemonpregnantwomenornursingmothers.
• Beforeturningthelasersystemon,operatingroompersonnelandthepatientshouldbewearingprotectiveeyewearsuitableforthelaserenergy.
• Abasinofwatershouldbeavailableincaseafireshouldoccur.
• Donotpresseitherfootswitchwhilecheckingtheaimingbeam.
• Toavoiddamagefromthetreatmentbeamoritsbackscatter,itisrecommendedthefiberbefullyvisibleinthevisualfield.Donotfirethe
laser unless the aiming beam is visible and directed at the intended target. Aim and use the laser only on tissues that are in full view.
• Avoidfiringthelaserifthefibertipisinanairpocket.
• Donotburythefiberintissue.Donotusethefiberasaprobe.
• Firingtheworkingbeamcontinuouslyatonelocation(notsweepingthebeam)mayresultindifficulttocontrolbleedingorperforation.
• Ifextendedcontactbetweenthefibertipandtissueisunavoidable,usethelowestpoweratwhichacceptablevaporizationcanbe
achieved, but no more than 80 W.
• Iftheworkingbeamoraimingbeamexitsthefiberinanunusualdirection,ceasefiringimmediately,determineiftherehasbeenunintended
tissue damage and take appropriate action. Replace the fiber before continuing with the procedure.
• Thesurgeonshouldcarefullyassessthetargetandsurroundingtissue,andthenbeginatthelowestappropriatepower,withshortduration
exposures.Donotadjustthepowerofthelaseruntiltheeffectofthelaseronthetissuehasbeenevaluated.Notethesurgicaleffectand
adjust the settings and sweeping speed until the desired effect is obtained.
• Useoflowerpowerlevelsandshorterexposuretimesarerequiredtopreventthermaldamagetounderlyingstructures,forexample,tothin-
walled structures, such as the bladder.
• Tissueperforationcanoccurifexcessivelaserenergyisapplied.Thiscanoccurusingexcessivelaserpowerortheapplicationofpower
for excessive periods of time, particularly on diseased tissue. Examples of diseased tissue include tissue that has undergone brachytherapy,
tissue that is infected, or tissue that has thinned due to another underlying disease other than BPH.
• Usecautionwhenlasingtissueincloseproximitytoknownarteries,nerves,andveins.
• Usecautiontoprotectendotrachealtubesfromlaserradiation.Ignitionorperforationofendotrachealtubesbythelaserbeamcouldresult
in serious or fatal patient complications.
• Thelasermaynotbeeffectiveforcoagulationinmassivehemorrhagesituations.Thesurgeonmustbepreparedtocontrolhemorrhages
with strident alternative non-laser techniques, such as ligature or electrocautery.
• Thesurgeonshouldschedulefollow-upvisitsinthesamemannerasforpatientsundergoingsuchsurgerywithothermodalities.
• Exercisecareforspecialrisksrelatedtothedisposalofthedevice.SeeEndofUsefulLifesection.
• Thelasersystemmustbekeptdryduringstorageandtransportwithtemperaturesbetween:
• 32°Fto104°F(0°Cto40°C)withallwaterdrainedfromsystem
• 39°Fto104°F(4°Cto40°C)withcoolingsystemchargedwithdistilledordeionizedwater
Improper storage or transport of the laser system may result in damage to the cooling system, optical resonator, and other critical components.
6 ADVERSE EVENTS
Users should read and understand the specific indications, contraindications, warnings, precautions, and current adverse events included with
the fiber used in conjunction with the GreenLight XPS™ Laser System. Potential adverse events associated with the GreenLight XPS Laser System
are, but not limited to, the following:
• Abdominalbloating(intestinalgas)
• Acuterenalfailure
• Allergicreaction
• Aspiration
• Bladderneckcontracture
• Bladderspasm
• Bleeding
• Burn
• Chills
• Clotretention