Endoscope, Neurological

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-03-02Open, ClassifiedUnder Investigation by firm

  Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A

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

• 2025-03-06Open, ClassifiedProcess control

  AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80

  Possibility for the obturator to break (separate).

• 2024-07-11Open, ClassifiedProcess change control

  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.

• 2023-09-06Open, ClassifiedProcess change control

  For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

  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.

• 2017-03-20TerminatedNonconforming Material/Component

  AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.

  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.

• 2012-05-11TerminatedComponent design/selection

  Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.

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

• 2012-03-08TerminatedNonconforming Material/Component

  Visionsense Stereoscopic Vision System, Brand name VSII, Model/Part Numbers 172-0030 and 172-0040 --- Classification Name: Neurological Endoscope --- NOTE: Model Numbers 172-0032, 172-0044, 172-0070, 172-0072, 172-0080 were also included in the firm's recall action but these never entered US commerce. These were distributed directly from Israel to the foreign consignees. --- The VSII is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures. These devices do not carry an expiration date. However, they are automatically taken out of service and replaced after 40 uses.

  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

• 2012-02-19TerminatedNonconforming Material/Component

  ASSISTO Arm System Table-mounted self retaining instrument holder system consisting of stainless steel tubular, articulated arms. Product Usage: ASSISTO Arm Systems with a holding power of up to 50N are designed as universal support systems for ventilator tubing and breathing tubes. When equipped with the appropriate accessories these arm systems may also be used to hold endoscopes. They are usually proved with non-insulated clamp sockets. All ASSISTO Arm Systems with a holding power of up to 100N are designed as universal support and holding systems for endoscope holders and detractors or other accessories. These systems are attached to the operating table with an electrically insulated clamp socket and are designed to hold the accessory in the desired position for a short period of time (which may exceed 60 minutes.

  The product may fracture during surgical procedures.

• 2005-10-21TerminatedOther

  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.

• 2005-10-21TerminatedOther

  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.