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

Model Number	G-SERIES SURGICAL LIGHTING SYSTEM
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the surgical lighting system and found that the tension of the lighthead spring arm required adjustment.As the tension of the lighthead spring arm required adjustment, this allowed the spring arm to drift slowing downwards in height subsequently causing the reported event to occur.The technician adjusted the spring arm tension, tested the surgical lighting system and confirmed the unit to be operational.The device was returned to service and no additional issues have been reported.
Event or Problem Description
The user facility reported that the lighthead from their harmonyair g-series surgical lighting system came down and "struck" an employee's head.No report of injury.No medical treatment was sought or administered.

• 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: 17135919
• Report Number: 1043572-2023-00115
• Device Sequence Number: 5773665
• Product Code: FSY
• UDI-Device Identifier: 00724995191979
• UDI-Public: 00724995191979
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/15/2023

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: G-SERIES SURGICAL LIGHTING SYSTEM
• Device Catalogue Number: LG07
• 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
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2017
• 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