MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR G SERIES SURGICAL 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	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the lighting system and found the damaged cover had already been replaced by the facility biomed.The technician confirmed the lighting system was operational and checked the cover to ensure it was intact and properly secured.No issues were identified.Upon further investigation, the technician learned the cover subject of the reported event had the screw to secure the cover and a portion of the cover still intact after the reported event.The event is likely attributed to damage from user(s) impacting, or allowing impacts upon the affected lighting system cover.The harmonyair g-series surgical lighting system operator manual (10043124) states the following caution statement within the safety precautions section of that manual."caution - possible equipment damage - do not bump lightheads into walls or other equipment." steris account manager offered in-service training on the proper use and operation of the harmonyair g-series surgical lighting system; however the customer has not yet responded.A follow up report will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure a cover from their harmonyair g-series surgical lighting system fell onto the patient.The patient was administered antibiotics as a preventative action and the sterile field was reestablished subsequently causing a delay; the procedure was completed successfully with no report of injury.
Additional Manufacturer Narrative
Steris account manager offered in-service training on the proper use and operation of the lighting system; however, the user facility declined.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: 19579984
• Report Number: 1043572-2024-00044
• Device Sequence Number: 3433824
• Product Code: FSY
• UDI-Device Identifier: 00724995166960
• UDI-Public: 00724995166960
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/20/2024

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
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2017
• 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