MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; SURGICAL LIGHTING SYSTEM

Model Number	A-SERIES LIGHTING SYSTEM
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	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, one of the lightheads from their harmonyair a-series surgical lighting system disconnected from the yoke arm.User facility personnel were able to secure the lighthead and move it out of the way.A procedure delay occurred due to the re-setup; the patient procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician inspected the harmonyair a-series surgical lighting system and found that the retaining ring was not in the grove spindle.As the retaining ring was not in the grove spindle, this allowed the lighthead to disconnect from the yoke arm.The steris technician removed the lighting system from service and is awaiting a new lighthead.A complaint review considers this to be an isolated event.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The steris service technician received and installed a new light head and spring arm for the harmonyair a-series surgical lighting system, tested the system and confirmed it to be operating according to specification.The steris service technician returned the harmonyair a-series surgical lighting system to service; no additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: HARMONYAIR
• Common Device Name: SURGICAL LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 18151578
• Report Number: 1043572-2023-00163
• Device Sequence Number: 6721597
• Product Code: FSY
• UDI-Device Identifier: 00724995187989
• UDI-Public: (01)00724995187989(11)230411(21)ORAPAR1462476412
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2023

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: LAS02IN01
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 10/16/2023; Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 01/23/2024; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown