MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; HARMONYAIR E-SERIES HIGH DEFINITION DUAL LIGHT

Model Number	E-SERIES
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the lighting system and found that the yoke assembly had come loose from the spring arm.Additionally, the technician found that the retaining key and shaft components for the yoke assembly were both worn.The steris service technician ordered the replacement retaining key and yoke shaft components.The unit has been removed from service pending repairs.The damaged components were not returned to montgomery for evaluation.A root cause of the reported event could not be determined.Steris will continue to monitor for similar events.A follow-up report will be submitted once the repairs have been made.
Event or Problem Description
The user facility reported that during a patient procedure the yoke assembly of their harmony air e-series surgical lighting system detached from the spring arm and was hanging by the cables resulting in a short procedure delay.The yoke assembly was resecured to the spring arm by user facility personnel, and the procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The evaluation revealed that an inadequately greased spring arm can allow for the metals on the dpfm accessory to wear over time.The connection between the aluminum adapter and the sheet metal key cover causes wear on the aluminum adapter.The wear is especially present when there is no lubrication on the adapter resulting in excessive force being applied to the sheet metal key cover, causing it to deform.This pushes the key out of the keyway and eventually causes the key to detach from the adapter.Steris conducted an in-depth analysis of this issue.Testing revealed that yoke assemblies that were not greased at all showed major wear on the mating surfaces at less than 500 cycles (rotations).Note: the average annual expected usage of the yoke assembly is approximately 1,530 cycles.The testing was then repeated with a greased yoke assembly which showed no wear after more than 4,500 cycles.Based on the testing conducted, annual cleaning and greasing of the dfpm yoke assembly will prevent this issue from occurring.Steris initiated a recall (correction) of affected dfpm accessories on may 29, 2025.This unit will be addressed as part of this recall.

• Brand Name: HARMONYAIR
• Common Device Name: HARMONYAIR E-SERIES HIGH DEFINITION DUAL LIGHT
• 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: 20632084
• Report Number: 1043572-2024-00071
• Device Sequence Number: 15489919
• Product Code: FSY
• UDI-Device Identifier: 00724995172732
• UDI-Public: (01)00724995172732(11)201217
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: E-SERIES
• Device Catalogue Number: LEH02IN02T
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1527821-05292025-002-C
• Patient Sequence Number: 1
• Patient Sex: Unknown