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

Model Number	E-SERIES
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the harmony air e-series surgical lighting system and confirmed chipped paint on the unit.The unit is not under steris agreement for maintenance, the user facility is responsible for all maintenance activities.The damage to the painted finish is attributed to impact(s) sustained by the lighting system from other equipment.The harmony air e-series surgical lighting system operator manual is provided with every harmony air e-series surgical lighting system sold.The manual includes the following statements within the safety precautions section: "caution - possible equipment damage do not bump lightheads into walls or other equipment.Always use handles or gripping surface when positioning lighthead during surgical procedures, or when cleaning or servicing the lighting system." steris offered in-service training to the user facility on the proper use and operation of the harmony air e-series surgical lighting system, specifically not bumping the lighthead into other equipment; however, the user facility declined.The unit has been removed from service pending repairs.No additional issues have been reported.
Event or Problem Description
The user facility reported that a paint chip from their light spindle fell into the sterile field during a patient procedure.The light spindle is attached to the harmony air e-series lighting system.No report of injury or procedure delay.
Additional Manufacturer Narrative
Steris service technician applied touch up paint to the light spindle and returned it to service.No additional issues have been reported.

• 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; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19828043
• Report Number: 1043572-2024-00050
• Device Sequence Number: 8589173
• Product Code: FSY
• UDI-Device Identifier: 00724995173746
• UDI-Public: (01)00724995173746
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 07/25/2024

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: LES01IN01
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown