Operating Room Accessories Table Tray

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

• 2024-03-12Open, ClassifiedUnder Investigation by firm

  STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192

  Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.

• 2017-04-19TerminatedProcess control

  216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.

  Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying carbon fiber structure of the Wilson frame and could lead to a pressure injury.

• 2015-11-09TerminatedUnder Investigation by firm

  Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal region in the vertical position with regard to the spine and the large blood vessels there. This positioning method is thus suitable for interventions on the spine with dorsal access to prevent positioning-specific compression with resulting bleeding tenancies. They are made up of the following components: (2) chest and (2) hip elements with padding which are secured in a fixed arrangement to the frames and can be adjusted in all directions independently of each other.

  Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) for lumbar spine surgery. The hip elements may have a negative effect on patients- venous backflow under certain conditions and may have been a contributing factor to thromboembolic events.

• 2015-11-09TerminatedUnder Investigation by firm

  Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical interventions as well as for examination and treatment. With a patient in the prone position, the adjustable positioning elements stabilize the upper body while simultaneously relieving the abdominal region in the vertical position with regard to the spine and the large blood vessels there. This positioning method is thus suitable for interventions on the spine with dorsal access to prevent positioning-specific compression with resulting bleeding tenancies. They are made up of the following components: (2) chest and (2) hip elements with padding which are secured in a fixed arrangement to the frames and can be adjusted in all directions independently of each other.

  Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) for lumbar spine surgery. The hip elements may have a negative effect on patients- venous backflow under certain conditions and may have been a contributing factor to thromboembolic events.

• 2015-02-10TerminatedNonconforming Material/Component

  The MAYFIELD Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.

  Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.

• 2014-12-16TerminatedPackaging

  Arthroscopy Pack, Catalog number 900-1042. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

  Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

• 2014-12-16TerminatedPackaging

  Arthroscopy Pack, Catalog number 900-1062. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

  Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

• 2014-12-16TerminatedPackaging

  Knee Arthroscopy Pack, catalog #900-2123 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

  Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

• 2014-12-16TerminatedPackaging

  Arthroscopy Pack, catalog #900-2609 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

  Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

• 2014-12-16TerminatedPackaging

  Arthroscopy Pack, Catalog number 900-620. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

  Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.