MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION RIGHT- YELLOFIN STIRRUPS W/ LFT-ASSIST; OPERATING ROOM ACCESSORIES TABLE TRAY

Model Number	O-YFASI-R
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
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 technician ran a function test on the stirrup.The baxter technician thoroughly inspected the stirrup and was unable to duplicate the reported issue.The stirrup functioned as designed.However, if the reported event of a stirrup dropping were to recur, it would be likely to cause or contribute to death or serious injury, therefore baxter considers this event reportable.
Event or Problem Description
Baxter received a report stating that a rt yellofin strups w lftasst was not holding position and kept dropping.The patient was uninjured, and the procedure was finished without incident.No harm or significant impact to the surgical procedure was reported.

• Brand Name: RIGHT- YELLOFIN STIRRUPS W/ LFT-ASSIST
• Common Device Name: OPERATING ROOM ACCESSORIES TABLE TRAY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM MEXICO; ave.del telefono; no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24259565
• Report Number: 3006697241-2026-00042
• Device Sequence Number: 15840308
• Product Code: FWZ
• UDI-Device Identifier: 00615521020132
• UDI-Public: (01)00615521020132(11)250214
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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-YFASI-R
• Device Catalogue Number: O-YFASI-R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/04/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown