MAUDE Adverse Event Report: STERIS CORPORATION POWERLIFT PLUS STIRRUPS

Model Number	POWERLIFT PLUS
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure their powerlift plus stirrups would not remain in the lock position.The procedure was completed successfully without report of delay.No report of injury.
Additional Manufacturer Narrative
The powerlift stirrups subject of the reported event were returned to the supplier for evaluation.The supplier's evaluation found no issue with the function or operation of the stirrups; the reported event could not be duplicated.The powerlift stirrups instructions for use states, "the boot has a self-adjusting design to protect the calf during raising or lowering of the legs.It is free floating and moves with the patient's leg as needed.".A steris account manager performed in-service training with user facility personnel on the proper use and operation of the stirrups.No additional issues have been reported.

• Brand Name: POWERLIFT PLUS STIRRUPS
• Common Device Name: STIRRUPS
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 22104404
• Report Number: 1043572-2025-00052
• Device Sequence Number: 8149755
• Product Code: EYD
• UDI-Device Identifier: 00724995217280
• UDI-Public: (01)00724995217280(11)250116
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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
• Operator of Device: Health Professional
• Device Model Number: POWERLIFT PLUS
• Device Catalogue Number: BF867
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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