LithoVue™ Elite Single-Use Digital Flexible Ureteroscope

The LithoVue Elite Digital Flexible Ureteroscope System is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

• Contraindications for this device are those specific to urinary tract endoscopy.
• Diagnostic or therapeutic ureteroscopy is contraindicated in people with an untreated urinary tract infection.
• Contraindications to therapeutic ureteroscopy (e.g., lithotripsy, endopyelotomy, tumor therapy) are more numerous and can mirror those associated with the corresponding open surgical interventions. Consideration should be given to the contraindications for those procedures.

This is not a complete list of warnings. All warnings can be found in the product labeling supplied with each device.

• Do not advance the ureteroscope with an articulated end, as this may result in a patient harm.
• Do not force the distal tip of the LithoVue Elite ureteroscope against the sidewall of the ureter or renal pelvis. Doing so can cause patient injury such as perforation, avulsion, hemorrhage, or urothelial damage.
• In the event that the live video image becomes lost or is unusable during the procedure, STOP - DO NOT ADVANCE THE URETEROSCOPE, DO NOT INSERT, ADVANCE, OR ACTUATE PROCEDURAL DEVICES IN THE WORKING CHANNEL. Blind manipulation of the ureteroscope can result in patient injury such as avulsion, perforation, stenosis and an unretrieved device fragment, and/or ureteroscope damage.
• In the event of a loss of articulation control, STOP - DO NOT ADVANCE THE URETEROSCOPE, DO NOT INSERT, ADVANCE, OR ACTUATE PROCEDURAL DEVICES IN THE WORKING CHANNEL.
• Ensure the articulation lever is in the neutral position when removing the LithoVue Elite Ureteroscope from the patient.
• Not following the instructions on the console during the initialization of the pressure sensor may lead to inaccurate pressure readings which may lead to excessive fluid and/or pressure being delivered to the patient and may result in patient injury such as distention, infection, inflammation, renal failure or tissue damage.
• Do not set the pressure limit to an unnecessarily high value to render the alarm useless. Doing so may result in excessive fluid to be delivered to the patient.
• To prevent the risk of misinterpretation of pressure data, ensure that the intended unit of pressure is selected.
• Do not rely on the pressure readings if the pressure sensor is obstructed (e.g., tissue, biomass, debris, stone) since this may result in the pressure readings to be inaccurate. Doing so may result in excessive fluid/pressure to be delivered to the patient and may cause patient injury such as infection, distension, and other fluid overload related harms.
• When considering the pressure readings, exercise clinical judgment as the clinical implication of intrarenal pressure measurements may vary depending upon a variety of patient and procedural factors.
• When the pressure limit set for the procedure is exceeded, before continuing to irrigate, exercise clinical judgment as the clinical implication of intrarenal pressure measurements may vary depending upon a variety of patient and procedural factors.
• Do not look directly into the light emitted from the LithoVue Elite ureteroscope. Doing so can result in eye injury.
• Do not excessively bend the flexible shaft or the articulating section of the ureteroscope as this may break or kink the shaft.
• The LithoVue Elite System has been tested and shown to be compatible with laser lithotripsy devices. The use of other energized procedural devices may cause loss of image, device damage, or patient injury such as burn, erectile dysfunction, hematoma, hemorrhage, nerve injury, perforation, reflux (genitourinary), restenosis, stenosis, and urinary retention.
• To ensure satisfactory performance, perform the prescribed inspections and operational checks described in the device preparation section before use.
• If the Console stops functioning during a procedure, follow the procedure described in “TROUBLESHOOTING” section.