PNEUMOLINER FDA-REQUIRED SURGEON TRAINING:

Contained Tissue Extraction System

PneumoLiner
Containment Device

The PneumoLiner is uniquely designed to:

• Conform to each patient's abdominal size, avoiding intra-abdominal folding of material which can restrict movement, visualization, or inadvertent capture by the morcellator.
• Provide a barrier between target tissue and non-targeted abdominal contents.
• Maintain a barrier to the escape of fluids, cells and tissue fragments.

FDA Clearance & Letters:

• De Novo Decision Letter
• No latex letter

WARNING: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.

CONTRAINDICATIONS: Do not use on tissue that is known or suspected to contain malignancy. Do not use for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal; or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision. Do not use in women with undiagnosed uterine bleeding. Do not use this device on patients with known or suspected allergies to polyurethane. Do not use where the abdominal wall thickness is larger than 10cm. This device should only be used by physicians who have completed the formal validated training program administered by Olympus and/or Advanced Surgical Concepts.

For more information, please read the full PneumoLiner Instructions for Use for indications, additional contraindications, warnings and precautions.

For additional information, please view the videos below from AAGL 2015.

PK Morcellator

The PK Morcellator design features:

• Anti-Coring Tip - Integrated peeling tip promotes peeling on target tissue and avoids tissue coring throughout the procedure.
• Reduced Surgical Smoke - The smoke management of the PK Morcellator maintains clear visibility of the morcellator, the target tissue and collateral tissue compared to PKS PlasmaSORD.
• Faster Morcellation Speed - PK Morcellator completes morcellation at a faster rate than PKS PlasmaSORD.

FDA Clearance & Letters:

• 510k Letter

WARNING: Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.

CONTRAINDICATIONS: The use of the PK Morcellator is contraindicated for surgical procedures in which the tissue to be morcellated is known or suspected to contain malignancy. The PK Morcellator is contraindicated for removal of uterine tissue containing suspected fibroids in the following patient groups:

• Peri- or post-menopausal patients.
• Candidates for en bloc tissue removal. For example, through the vagina or via a mini-laparotomy incision.

The use of the electrosurgical generator ESG 400 is contraindicated when, in the judgment of the physician, bipolar electrosurgical procedures with the PK Morcellator would be contrary to the best interests of the patient or user. For patients with active electronic devices implanted, refer to the instructions for use for those devices before using bipolar electrosurgery.

The PK Morcellator should not be used if the patient is not considered suitable for a laparoscopic hysterectomy procedure or a laparoscopic myomectomy procedure.

For additional information, please view the videos below from AAGL 2015.

Videos

PATIENT