Endoscope, Neurological

Brand Name: AESCULAP

There is the potential for the length of the trocar shaft to be too long.

AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/6

Possibility for the obturator to break (separate).

AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.

Potential sheath damage that could lead to tissue damage and/or track hemorrhage.

For intraventricular indications mainly used for operations within the brain ventricles.

Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30 neuroendoscope, a portion of the visual field is obscured.

AESCULAP MINOP InVent 30 Trocar System, non-sterile

Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.

Mitaka Point Setter, holding system for surgical instruments.

Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.

Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and 172-0040 --- Classification Name: Neurological Endoscope --- NOTE: Mode

A complaint was received and a unit returned that exhibited the metal and glass shaft window becoming dislodged during scope cleaning. Additionally, during in-process visual inspection of the metal and glass shaft window sub-assembly from a specific batch that was received from the supplier it was noted that the window at the tip of the scope was not seated properly. It was determined that the wi

ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel tubular, articulated arms.

The product may fracture during surgical procedures.

Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized.

The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.

Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets, Size 8 French, Sterile: Single Use/Disposable Radiopague Contents Ethylene Oxide Sterilized

The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.