MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION YELLOWFINS APEX RIGHT STIRRUP; OPERATING ROOM ACCESSORIES TABLE TRAY

Model Number	O-YFAX-R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
These stirrups are designed to position and support the patient¿s foot, lower leg and upper leg in a variety of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and robotic surgery.These devices are intended to be used by healthcare professionals within the operating room setting.The yellow fin allen stirrup is used in placing the patient in the lithotomy position in preparation for a procedure.The ifu states you should always confirm the working order prior to using it clinically, and whenever practical, a patient should be placed in the stirrups prior to anesthesia.Upon inspection, baxter field service technician determined that the shock was damaged.A replacement shock was installed by the baxter field service technician.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of a collapsing leg section 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 during a total shoulder procedure, a yellofins apex rt strup had the leg section collapsing.This occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: YELLOWFINS APEX RIGHT STIRRUP
• Common Device Name: OPERATING ROOM ACCESSORIES TABLE TRAY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; 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: 24314753
• Report Number: 3006697241-2026-00060
• Device Sequence Number: 20049280
• Product Code: FWZ
• UDI-Device Identifier: 00615521030605
• UDI-Public: (01)00615521030605
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: Other
• Device Model Number: O-YFAX-R
• Device Catalogue Number: O-YFAX-R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/11/2026
• 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