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

Model Number	O-YFAX
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that yellofins apex strup pair had the stirrup dropped unexpectedly.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
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.Baxter technical support provided the account the part number of the device to resolve the issue.The account will repair the stirrup themselves.Based on this information, no further action is required.Although there was no reported injury with this event, if the report of a movement or drop while locked in position 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: 50681355
• Report Number: 3006697241-2026-00337
• Device Sequence Number: 5316179
• Product Code: FWZ
• UDI-Device Identifier: 00615521030629
• UDI-Public: (01)00615521030629
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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
• Device Catalogue Number: O-YFAX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/09/2026
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown