Thuvera™ Thulium Fiber Laser System

IFU #MD2600F-001956 Rev. B

The Thuvera Laser System is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology and lithotripsy.

Urology:

• Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
• Laser Resection of the Prostate (LRP)
• Laser Enucleation of the Prostate (LEP)
• Laser Ablation of the Prostate (LAP)
• Transurethral Incision of the Prostate (TUIP)
• Condylomas
• Urethral strictures
• Lesions of external genitalia
• Bladder neck incisions (BNI)
• Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
• Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy:

• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
• Endoscopic fragmentation of renal calculi
• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

The use of the laser system consistent with the indication for use in this IFU are at the discretion of the physician except in cases where the following conditions are specifically contraindicated:

• Inability to receive endoscopic or laparoscopic treatment
• Intolerance to anesthesia
• Resection or excision of large, highly vascularized organs
• Carcinoma of the prostate
• Septic peritonitis
• Intestinal obstruction
• Septic shock
• Patients under the age of 18 years old

Doctor, patient, assistant and all others inside or entering the operating room must wear appropriate laser protection eyewear for the 1940nm wavelength, OD (3) or greater whenever the laser is in user. Prior to use, inspect eyewear for pitting and/or cracking. Do not use if damaged.

The following are possible risks of laser treatment. Please refer to Operation section of the IFU [Thuvera System IFU], the Thuvera Surgical Fiber IFU, and appropriate medical literature for additional details.

• Mild mucosal injury
• Transient urinary incontinence
• Urinary tract infection
• Post-operative bleeding
• Transient urethral stricture
• Fever
• Clot retention
• Bladder neck sclerosis

IFU # MD2600F-002007 Rev B

The Thuvera Surgical Fibers are intended for use in incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology and lithotripsy. Reference the “Thuvera Laser System: Instructions for Use” for specific information on indications for use.

The Thuvera Surgical Fiber is contraindicated for treatment of patients for whom endoscopic procedures are not recommended. Refer to the Thuvera Laser System IFU for contraindications and potential adverse effects that are specific to each surgical specialty.

Using the Thuvera Surgical Fiber improperly can result in unintended fire, perforated soft tissue, or exposure to laser emissions resulting in skin injury, eye injury, or serious injury of the user, operating room personnel, or patient. To prevent serious injury, users must follow these safety rules:

• No modification of this equipment is allowed.
• Rarely, the tip of the surgical fiber can break.
  • Respond to this condition by visually locating the tip using an appropriate scope and remove the tip using a basket or another surgical instrument. Irrigate the area to remove traces of the tip.
• Do not bend or coil the surgical fiber beyond the recommended minimum bend radius (refer to Table 2 on page 5 of the Thuvera Single-Use Laser Surgical Fibers IFU).
  • Bending the surgical fiber beyond its limits can result in light leakage and fiber breakage that could cause exposure to laser emissions and injury when the laser is used.
• When checking surgical fiber quality as described below, inadvertently or purposely using the surgical treatment laser beam—instead of the aiming beam—can result in severe skin and eye injury from laser emissions, as well as damage to the target.
  • To prevent injury, only use the aiming beam, not the surgical treatment laser beam when checking surgical fiber quality.
  • Use the Thuvera Laser System IFU to guide the operation and settings for the procedure.
  • Do not apply therapeutic laser emission until the surgical fiber is aligned with treatment area and fiber integrity has been verified.

Using the Thuvera Surgical Fiber improperly can result in unintended damage to the surgical fiber, making it unusable. To prevent damage to the surgical fiber, follow these rules:

• Do not expose the surgical fiber to ultraviolet light, ionizing radiation, or organic solvents. 
• Keep the inside of the surgical fiber’s connector clean. If contaminated, dispose of the surgical fiber. 

The potential for complications in endoscopic laser surgery is similar to those normally experienced with conventional endoscopic surgery. The patient may experience fever and leukocytosis following laser surgery as is commonly associated with tissue destruction. If a question of infection arises from laser- ablated necrotic tissue or infection, appropriate treatment should be carried out.