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

Model Number	M-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	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the cover to their harmonyair m-series surgical lighting system detached during a procedure, entering the sterile field.A procedure delay occurred as the sterile field was re-established.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the harmonyair m-series surgical lighting system and confirmed that the cover had detached.The reported event is indicative of facility personnel bumping the lighting system into other pieces of equipment.The technician replaced the light head cover, tested the lighting system, confirmed it to be operating according to specification, and returned it service.The harmonyair m-series surgical lighting system operator manual states (1-4), "caution - possible equipment damage hazard: 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." the technician counseled user facility personnel on the proper use and operation of the harmonyair m-series surgical lighting system, specifically the importance of not bumping the lighting system into other pieces of equipment.No additional issues have been reported.

• Brand Name: HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM
• Common Device Name: 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 ; 4403927453
• MDR Report Key: 16822725
• Report Number: 1043572-2023-00094
• Device Sequence Number: 17826489
• Product Code: FSY
• UDI-Device Identifier: 00724995191542
• UDI-Public: 00724995191542
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 04/27/2023

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: M-Series Surgical Lighting System
• Device Catalogue Number: LMH01
• 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: 03/29/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2016
• 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