A device that crushes tissue for laparoscopic elimination of large hardened masses, supracervical hysterectomy, and laparoscopic myomectomy. See Laparoscopic hysterectomy.

The Tissue Morcellator is a single-patient-use device. These devices is inserted to the patient by using the provided single-patient-use Obturator. The device allows tissue to be grasped having a standard grasping instrument extended through its central lumen. The tissue can be drawn up inside the device’s central lumen into the inner stationary sheath since the exposed blade cuts the tissue. The doctor can activate the Tissue Morcellator using a foot pedal or through the dual-function Blade Guard/Activation Trigger about the device’s Detachable Handle. The device can operate in either coring or peeling mode in line with the level of exposure of the blade and site of the rotatable Coreguard. The device is packaged with a single-patient-use reducer cap to permit the not compulsory use of a 5mm instrument.

The next features are highlighted

1. Coreguard
2. Coreguard Rotating Knob
3. Blade Housing Assembly
4. Blade Position Selector
5. Detachable Handle
6. Blade Guard / Activation Trigger
7. Handle Detachment Button
8. Flexible Drive Cable
9. Detachable Handle Air Tube
10. Obturator
11. Reducer Cap

The variable-speed, reversible drives the rotation of the blade from the Tissue Morcellator at a controlled speed and torque after connection of the device towards the MDU through the Flexible Drive Cable. An operating room staff member outside the sterile field controls the direction and speed of rotation about the MDU.

INTENDED USE: The Tissue Morcellator is supposed for gynecologic, urologic and general surgical endoscopic use by trained professionals in hospital environments and ambulatory surgery centers.

INDICATIONS: The Tissue Morcellator is indicated for cutting, coring and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures and laparoscopic gynecologic procedures.

CONTRAINDICATIONS

The Tissue Morcellator is contraindicated for use on vascularized tissue or as a dissecting tool. All target tissues and organs should be devascularized and dissected before morcellation.

WARNINGS:

• Failure to softly follow all applicable instructions may result in significant injury to the patient, physician or attendants and could have an adverse effect on procedural outcomes.
• The Tissue Morcellator is a precision instrument that must be handled carefully by well-trained and knowledgeable professionals. Carefully inspect these devices and all associated equipment, instrumentation and cabling for damage just before use. DO NOT attempt to operate this instrument if any damage is observed.
• To prevent accidents to the abdominal wall or similar structure, the tissue to become morcellated should be completely exposed before applying these devices. In addition, it is recommended that the second pair of grasping forceps or a fixation instrument be employed to prevent large pieces of tissue from uncontrollably moving. Unintended movement of the device may cause significant injury.
• DO NOT attempt to sharpen or modify the blade from the device. Bent or distorted blades can result in patient or physician injury and equipment damage.
• Use caution when introducing or removing instruments to prevent inadvertent damage to device seals. Additional care should be used when inserting sharp or anglededged endoscopic instruments to prevent tearing of the seals.

PRECAUTIONS:

• The doctor must be thoroughly familiar with and carefully follow all manufacturer’s instructions pertaining to this device and all associated accessories, equipment and instrumentation.
• Just like any endoscopic instrument, procedures performed using the Tissue Morcellator require adequate knowledge, training and preparation on the part of the doctor.
• The blade ought to be completely covered during insertion and elimination of the instrument. Exercise care when inserting or taking out the instrument. Insertion and elimination of the instrument ought to be performed under direct visualization all the time.
• This device is supposed for single patient use. Reuse of this device (or portions of the device) may produce a risk of product degradation and cross-contamination, which can lead to infection or transmission of bloodborne pathogens to patients and users.
• CAUTION: Do not place the exposed blade in contact with tissue that is not supposed to have been morcellated. Exercise caution while governing the device at all times.
• CAUTION: The use of a tissue extraction bag is suitable for the morcellation of malignant tissue or tissue suspected of being malignant and for tissue how the physician considers to become possibly damaging when disseminated in a body cavity. As morcellation may affect endometrial pathologic examination, preoperative evaluation of the endometrium should be considered. Should malignancy be identified, use of the Tissue Morcellator may lead to dissemination of malignant tissue.

INSTRUCTIONS FOR USE

Placement of the Blade Housing Assembly to the Patient

1. Insert the Obturator with the central lumen from the Blade Housing Assembly.
2. Align the latches about the Obturator having a latch slot on top of the Blade Housing Assembly.
3. Press the Obturator into place by applying pressure. An audible “click” is heard once the obturator is securely placed into the Blade Housing Assembly.
4. Insert this assembly under direct visualization with an adequately sized incision.
5. After positioning the Blade Housing Assembly from the Tissue Morcellator, remove the Obturator by squeezing the latches about the Obturator inward and pulling the obturator out of the Blade Housing Assembly.
6. The Blade Housing Assembly can be utilized being an operative port before time that tissue morcellation is required.

Connection from the Flexible Drive Cable to the MDU

1. Locate the Drive Cable Receptacle about the front from the MDU and press down the metal tab until it locks into place.
2. Carefully insert the free end of the Flexible Drive Cable into the Drive Cable Receptacle about the MDU. Rotate the cable end from side-to-side until it engages.
3. Press within the surrounding fitting firmly until the metal tab releases and springs upward into place.
4. Make sure that the mode switch, on the back panel of the MDU, is set in the down position towards the “Morcellator” mode.
5. When the operator wishes to activate the motor via the foot pedal the operating room employee should connect the small tubing from the foot pedal (Pedal Air Tube) towards the back from the MDU. When the operator wishes to activate the motor through the Activation Trigger about the Detachable Handle, the operating room employee should connect the little tubing from the Detachable Handle cable (Detachable Handle Air Tube) towards the back of the MDU.

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