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

Model Number	A-SERIES LIGHTING SYSTEM
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported at the end of a patient procedure while repositioning their dual yoke assembly it detached from the spring arm.No report of injury or procedure delay.
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.Udi related data clarification - the model/catalog number are unknown; therefore, the applicable udi and production identifiers were not included in the mdr.
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 DEFINTION 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: 21046964
• Report Number: 1043572-2024-00083
• Device Sequence Number: 11615191
• Product Code: FSY
• UDI-Device Identifier: 00724995186050
• UDI-Public: (01)00724995186050(11)230309
• 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,Followup
• Report Date (Section B): 12/31/2024

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-SERIES LIGHTING SYSTEM
• Device Catalogue Number: LAS57NCNDT
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 08/22/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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