MAUDE Adverse Event Report: ALLEN MEDICAL SYSTEMS ALLEN YELLOFIN ELITE; OPERATING ROOM ACCESSORIES TABLE TRAY

Model Number	O-YFES
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a follow-up call with the customer, the customer reported that a root cause analysis conducted by the facility determined the injury was contributed to by use error.The customer stated that the patient underwent at 9¿12-hour colon surgery in the lithotomy/trendelenburg position.During the procedure, the patient was not moved or repositioned (for resting purposes) appropriately "except only a few times." additionally, the customer stated that additional "large pieces of purple foam" were used "inside the stirrup" for positioning purposes.The patient complained of uncontrollable left leg/calf pain while in the recovery room and was then returned to the operating room for a fasciotomy.The patient has been followed by an orthopedic surgeon, the wound is reportedly closed and the patient is believed to have recovered with no known permanent impairment.The customer has requested insight on the proper use of the stirrups to decrease the chances of the event from happening again, as well as requested additional training on the device for the surgical team and surgeons.The yellowfins 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, and general and robotic surgery.These devices are intended to be used by healthcare professionals within the operating room setting.In the lithotomy position, the patient begins supine, and the legs are lifted into low-padded stirrups.The arms are usually on arm boards.The potential hazards to the patient in the lithotomy position are skin breakdown, nerve damage, musculoskeletal injury (improper raising and lowering of the legs), and circulatory compromise.The ifu outlines the proper patient positioning guidelines including when using low lithotomy, "take care not to hyperextend the leg while achieving desired abduction, and when using medium or high lithotomy, use minimal initial leg flexion and abduction as both will increase as legs are raised." the ifu also recommends that "whenever practical, a patient should be placed in the stirrups prior to anesthesia", an alert patient can communicate normal range of motion limitations and to some extent, the patient's opposing muscles will guard against abnormal joint placement and stretching.During extended surgical procedures it is common practice and a preventive measure to check the patient's position ensuring that there is no undue pressure or obstruction of vascular supply to any body part, which includes allowing the patient's body to rest from an extended awkward position.Although the reported event is contributed to the improper positioning of the patient due to use error, the subsequent injury and the required surgical intervention are considered serious events, therefore, hillrom considers this complaint reportable.No malfunction reported by the customer.
Event or Problem Description
It was reported that the patient needed a fasciotomy following the use of the yellowfins stirrups due to improper positioning of the patient.This event was captured under hill-rom complaint ref # (b)(4).

• Brand Name: ALLEN YELLOFIN ELITE
• Common Device Name: OPERATING ROOM ACCESSORIES TABLE TRAY
• Manufacturer (Section D): ALLEN MEDICAL SYSTEMS; 100 discovery way; acton MA 01720
• Manufacturer Contact: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15579640
• Report Number: 3010216206-2022-00009
• Device Sequence Number: 6385450
• Product Code: FWZ
• UDI-Device Identifier: 00615521020149
• UDI-Public: 615521020149
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: O-YFES
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown