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Indications, safety, and warnings

LithoVue™ Elite Core Single-Use Digital Flexible Ureteroscope

Back to LithoVue™ Elite Core Single-Use Digital Flexible Ureteroscope

Brief Summary Document — HCP

Product

LithoVue Elite Core Single-Use Digital Flexible Ureteroscope  – IFU 51505539

Rx statement

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.  

Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions. 

Intended use/Indications for use

The LithoVue Elite Core 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

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.

Reuse Warning

Content supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative. 

For single use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient. 

Precautions

  • Only use the LithoVue Elite Core Ureteroscope in conjunction with the StoneSmart Connect Console. Connection to other controller or workstation devices may cause device or property damage or operator injury. 
  • The LithoVue Elite Core Ureteroscope is not compatible with the LithoVue System Workstation. 
  • The ureteroscope once plugged in will work for four hours.  

Potential adverse events

Possible complications include, but may not be limited to:

  • Avulsion 
  • Bleeding 
  • Burn 
  • Discomfort 
  • Extravasation 
  • Fever 
  • Hematoma 
  • Infection 
  • Inflammation 
  • Laceration 
  • Pain 
  • Perforation (ureter, renal pelvis, or bladder) 
  • Sepsis 
  • Stenosis/Stricture 
  • Ureteral reflux 
  • Urinoma 
  • Urothelial damage

Adverse events may result in an additional medical or surgical intervention or a prolonged procedure.