2�6 Adverse Events; How Supplied - Boston Scientific LithoVue Manual Del Usuario

• The distal tip of the LithoVue™ Flexscope should be straight when inserting and withdrawing
accessories. Follow the accessory directions for use regarding inserting the accessory into a
flexible ureteroscope. Failure to follow the accessory directions for use may result in patient
injury, or accessory and LithoVue Flexscope damage or malfunction.
• The LithoVue Flexscope features a strain relief at the transition from the handle to the shaft. The
strain relief protects the device during use. To prevent damage to the shaft and/or light fiber, do
not bend the shaft sharply.
• Use only those fluids/lubricants recommended in the compatibility section of the LithoVue Single-
Use Digital Flexible Ureteroscope Directions for Use or see Section 3.4 "LithoVue Flexscope
Fluid Compatibility".
• Do not use accessories that fail to meet the compatibility requirements of the LithoVue Flexscope
as stated in the LithoVue Single-Use Digital Flexible Ureteroscope Directions for Use. Doing so
may cause damage to the LithoVue Flexscope and/or accessory.
• The LithoVue Flexscope Connector Cable (hereafter referred to as Flexscope Cable) should connect
to the Workstation Receptacle easily. If the Flexscope Cable does not connect, verify that the
arrows on the Flexscope Cable and the Workstation Receptacle line up and that the Workstation
Receptacle is not damaged. Forcing the Flexscope Cable into the Workstation Receptacle may
damage the scope and/or System Workstation.
• Do not insert a wet, contaminated, or damaged Connector Cable plug into the System Workstation
as poor video performance or damage to the system may result.
• Do not remove the Connector Cable from the System Workstation by pulling on the cable as poor
video performance or damage to the system may result. Slide the locking collar on the Connector
Cable's plug toward the cable and pull the plug out to remove the cable.
• Placing the System Workstation near other medical electrical equipment may result in
electromagnetic interference (EMI) which may degrade the video image. Additionally, EMI from
the System Workstation may interfere with other equipment in the operating room. Verify that all
electrical equipment is working properly before starting the procedure. Failure to do so may result in
the equipment not working properly resulting in either a delay of the procedure or an adverse event.
• Spilling liquids on the System Workstation can damage it or cause it to shut down. Do not place
liquids above or near the System Workstation.
• During assembly and before each use, inspect all components for damage. Do not use a
component if it appears damaged. Contact Boston Scientific for service using the information
found in Section 8 "Service and Warranty".
2�6 AdVErSE EVEntS
Possible complications include, but may not be limited to:
• Bleeding
• Avulsion
• Stenosis/Stricture • Urinoma
• Inflammation
• Laceration

3 How Supplied

cAUtIon: Examine the System Workstation packaging� do not use if packaging has been
opened or the components appear damaged� do not use if labeling is incomplete or illegible�
10
Black (K) ∆E ≤5.0
• Pain • Sepsis
• Discomfort • Renal Failure
• Perforation (ureter,
• Infection renal pelvis or bladder)
• Fever • Hematuria
• Ureteral reflux
• Hematoma
• Urothelial damage
User's Manual