MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR G-SERIES SURGICAL LIGHTING SYSTEM

Model Number	G-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	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a procedure the plastic cover detached from their harmonyair g-series surgical lighting system and contacted the patient.The sterile field was reestablished resulting in a procedure delay, and the scheduled procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris technician arrived onsite following the event to inspect the harmonyair g-series surgical lighting system and found half of the cover was still installed on the lighting system and the retaining screw and plastic from the fallen cover were still in place where installed.It was observed that multiple tabs intended to secure the two cover halves together were broken and missing.Per the technician's discussion with facility personnel, the surgical lighting system had sustained impact damage resulting in the detachment of the cover.The harmonyair g-series surgical lighting system operator manual states (1-5), "caution -possible equipment damage: do not bump lightheads into walls or other equipment." the technician replaced the cover, tested the surgical lighting system, confirmed it to be operating according to specifications, and returned it to service.A steris account manager performed in-service training with facility personnel on the proper use and operation of the lighting system, including the importance of not bumping lightheads into other equipment or walls.No additional issues have been reported.

• Brand Name: HARMONYAIR G-SERIES SURGICAL LIGHTING SYSTEM
• Common Device Name: SURGICAL LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 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: 17134686
• Report Number: 1043572-2023-00116
• Device Sequence Number: 20454932
• Product Code: FSY
• UDI-Device Identifier: 00724995207595
• UDI-Public: 00724995207595
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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: G-Series Lighting System
• Device Catalogue Number: LG05V
• 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: 05/18/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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