MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALLEN YELLOFIN ELITE; OPERATING ROOM ACCESSORIES TABLE TRAY

Model Number	O-YFES
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lithotomy positioner stirrup is used in placing the patient in the lithotomy position in preparation for a procedure.The device's velcro strap, which secures the patient's foot and leg, is secured to the boot using a staple and adhesive.Ifu states you should always confirm the working order prior to using it clinically.In the event a device failure was to occur, or the device was thought to be unreliable, the device would not be used, and a backup device would likely be available for immediate use.Upon inspection, baxter technical support found the gas spring bolt got broken, causing the device to snap when weight was applied.Baxter technical support fitted a new gas spring and lower the joint plate.Based on this information, no further action is required.Although there was no reported injury with this event, if the report of a yellofin leg holder collapse were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.
Event or Problem Description
Baxter received a report stating that allen yellofin elite screw holding the hydraulics broke off and the housing fall apart.The bed was located at the account and occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: ALLEN YELLOFIN ELITE
• Common Device Name: OPERATING ROOM ACCESSORIES TABLE TRAY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; 100 discovery way; acton MA 01720
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22176212
• Report Number: 3010216206-2025-00012
• Device Sequence Number: 20788126
• Product Code: FWZ
• UDI-Device Identifier: 00615521020149
• UDI-Public: (01)00615521020149
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: O-YFES
• Device Catalogue Number: O-YFES
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Patient Sex: Unknown