MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALLEN; Operating Room Accessories Table Tray

Model Number	O-YFES
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that allen yellofin elite had stirrup does not stay tight.This occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
Record is showing that the stirrup was manufactured in 2008, making it over 10 years old and ineligible for repair.Stirrup is ineligible for repair due to age and the customer has been made aware of this.The customer advised that they scrapped the device once they were advised that it was unrepairable due to age and couldn¿t provide any more detail.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.Although there was no reported injury with this event, if the report of a stirrup dropping were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.

• Brand Name: ALLEN
• 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 NA 66640 ; MX 66640
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50465739
• Report Number: 3006697241-2026-00318
• Device Sequence Number: 13257454
• Product Code: FWZ
• UDI-Device Identifier: 00615521020149
• UDI-Public: (01)00615521020149
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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-YFES
• Device Catalogue Number: O-YFES
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown