Greenlight XPS - Further Explanation of Adverse Events; Bleeding Events Explained; Fever and Leukocytosis Explained; Pain Explained

6
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
• Contaminationofthedevicemayleadtoinjury,illness,ordeathofthepatient
• Deepvenousthrombosis
• Delayinhealing
• Dysuria
• Edema
• Embolism
• Epididymitis
• Erectiledysfunction(ED)
• Fatigueorweakness
• Fever
• Fluidoverload/hyponatremia
• Gasover-distension
• Hematospermia
• Hematuria
• Infection
• Leukocytosis
• Malfunctionoflaserfiberorconsoleresultinginaninjuryorprolongedprocedure
• Nocturia
• Overactivebladder
• Pain:
• AbdominalpainunresponsivetoNonsteroidalAnti-inflammatoryDrugs(NSAIDs)
• Armorlegpain
• Headache
• Back/lowbackpain
• Bodyaches
• Pelvic
• Penile
• Pelvichematoma
• Penileurethralinjury
• Perforation
• Pneumothorax
• Profuseperspiration(notfever-related)
• Prostatitis
• Pulmonaryembolus
• Retrogradeejaculation
• Sepsis
• Stricture
• Tissuedamage
• Tissuesloughing
• Ulceration
• Unretrieveddevicefragment
• Ureteralorificeinjury
• Urethralstricture
• Urgency
• Urinaryfrequency
• Urinaryincontinence
• Urinaryretention
• Urinarytractinfection
6.1 Some Adverse Events Further Explained
Bleeding: Patients may experience bleeding at the site of the laser therapy during or after laser therapy. Post-treatment hemoglobin and hematocrit
are recommended lab tests to assess the severity of bleeding.
Fever and Leukocytosis: Immediately after laser therapy, the patient may experience fever and leukocytosis, which are commonly associated with
tissue destruction. These generally resolve without treatment. Cultures may be indicated to exclude the possibility of infection.
Pain: Short-livedpainmayoccurimmediatelyafterendoscopic/cystoscopiclasertherapyandmaypersistfor48hours.