Olympus received FDA approval for PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook on January 4, 2022.
The PK Electrosurgical Instruments, including Needle, Spatula, and J-Hook are classified as electrosurgical cutting and coagulation surgical devices and accessories. These impedance controlled devices are compatible with the Olympus ESG-400 and ESG-410 generators. These devices decrease risks associated with traditional energy devices, minimize thermal damage, and can lead to reduced operation times.
The PK Needle is a 5mm bipolar instrument utilized in laparoscopic and general surgery procedures to resect soft tissue and blood vessels. Its blunt needle shaped tip can be activated by a button located on the handle or via a foot pedal.
The PK Spatula and PK J-hook are 5mm bipolar instruments utilized to both cut and coagulate soft tissue and blood vessels. The Spatula is intended for use only in dry environments and is used with a 5-way connector cable. When active, cut and coagulation mode can be applied simultaneously. The J-Hook has a J-shaped tip and can be activated by the handle button or via foot pedal. When active, cut or coagulation mode can be applied. Both the Spatula and J-Hook have a handle located nosecone that can change the orientation of the electrode tip with up to 330° rotation.
Non-clinical testing and risk analysis concluded substantial equivalence to the predicate device.
The FDA has determined that this device is substantially equivalent to a predicate devices. PK Electrosurgical Instruments (Needle, Spatula, and J-Hook) have been cleared and are a modification to device labeling in order to add compatibility with Olympus generator, ESG-410. The predicate device has no recalls.
The PK Needle can be utilized in laparoscopic general surgical procedures to resect soft tissue. It is particularly suitable for gynecological procedures such as treatment of ectopic pregnancy, myomectomies, and uterus amputation.
The PK Spatula and PK J-Hook can both be utilized in laparoscopic general surgical procedures to coagulate and resect soft tissue. The Spatula is particularly useful in myomectomies and uterus amputation. The J-Hook is particularly suitable for adhesiolysis and uterus amputation.
PK electrosurgical instruments should not be used in instances where laparoscopic surgery is contraindicated.
Olympus PK Hook-Spatula-Forceps