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

Model Number	O-YFES
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received an incident notification from bfarm stating that yellowfin leg holder crashed down with the patient's leg during a gynecological operation and fell off the standard rail.There was no patient/user injury, no harm or significant impact to the surgical procedure reported.
Additional Manufacturer Narrative
E1: initial reporter address - (b)(6).Baxter is in the process of inspecting the yellowfin 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 leg holder at this time.The investigation is ongoing.If any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a follow up report and the event will be categorized accordingly.
Event or Problem Description
Baxter received an incident notification from bfarm stating that yellowfin leg holder crashed down with the patient's leg during a gynecological operation and fell off the standard rail.There was no patient/user injury, no harm or significant impact to the surgical procedure reported.
Additional Manufacturer Narrative
E1: initial reporter address - (b)(6).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 account provided pictures of the device.Baxter technical support determined that there were device application errors causing the clamps to broke.Baxter technical support provided the account the part number of the clamps that needs to be replaced to resolve the issue.The account will repair the lithotomy positioner 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 yellowfin leg holder collapse were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• Brand Name: ALLEN YELLOFIN ELITE
• 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: 21681471
• Report Number: 3010216206-2025-00004
• Device Sequence Number: 8249223
• Product Code: FWZ
• UDI-Device Identifier: 00615521020149
• UDI-Public: (01)00615521020149
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: O-YFES
• Device Catalogue Number: O-YFES-R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/05/2025
• 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