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

Model Number	A-10052
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that during a case, they heard a pop in the right stirrup, a bolt had broken and the right leg slid forward.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
Baxter is in the process of inspecting the right stirrup.There was no allegation of patient or caregiver injury or death reported from this alleged incident.No further information is available on the repair of the bed at this time.The investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
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.The stirrup was received by baxter.Investigation indicated that there was no evidence of a malfunction.Baxter was unable to duplicate the alleged condition and the device performed as designed.A replacement stirrup was sent to the customer.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 sirrup collapsing during a procedure 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 case, they heard a pop in the right stirrup, a bolt had broken and the right leg slid forward.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• 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.; 100 discovery way; acton MA 01720
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20834074
• Report Number: 3010216206-2024-00033
• Device Sequence Number: 19802383
• Product Code: FWZ
• UDI-Device Identifier: 00615521001216
• UDI-Public: (01)00615521001216
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: A-10052
• Device Catalogue Number: A-10052-R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 07/18/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Patient Sex: Unknown