962000PK
Gyrus Acmi PKS PlasmaSORD Bipolar Morcellator
$175.50
eaches
Out of stock
Expiration:
Expired
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The item listed above is expired and may be used for educational, training, and non-clinical research purposes only. Any product information appearing below, including the product indication statement, pertains to an in-date item only.
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Description
PKS PlasmaSORD
962000PK
Device Only – Does Not Include Filter Accessory REF 274020
The PKS PlasmaSORD bipolar morcellator is the first completely bladeless solid organ removal device.
Please be advised that the PKS PlasmaSORD labeling has recently been revised to include the below information:
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.
CONTRAINDICATION: Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
CONTRAINDICATION: Laparoscopic power morcellators are contraindicated 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.
Key Benefits
- Efficient bipolar energy: Efficient bipolar energy to morcellate tissue instead of sharp, spinning blades.
- Ergonomic design: A lightweight, ergonomic handle designed to reduce hand fatigue in prolonged cases.
- Economical solution: Only one PKS PlasmaSORD device is required per case, thanks to its durable design.
Additional information
| Size | 1 |
|---|---|
| Arms | N/A |
| Manufacturer | |
| Unit | eaches |
- FDA Product Code: GEI
- FDA Product Code Name: Electrosurgical, Cutting & Coagulation & Accessories
- GMDN Term Code: 57944
- GMDN Term Name: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
- GMDN Term Description: A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.
