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

Model Number	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	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure a cover from their surgical light 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.
Additional Manufacturer Narrative
A steris service technician inspected the lighting system and found that the shell cover had broken off and the internal screw to be broken.As the internal screw was broken, this allowed the cover to detach and fall.While onsite, the steris service technician took pictures of the surgical light and sent them to steris quality for review.The pictures were reviewed, and it was observed that stress cracks were visible on the screw stand-offs as well as an orange-colored stain in the screw holes.The orange stain may be from an iodine based cleaning solution which is not a steris approved solution or method of cleaning.The technician replaced the light head cover and lighting shell, tested the surgical light and returned it to service.The operator manual harmonyair¿ surgical lighting system g series (rev.G) 10043124: states in the safety precautions section: "cleaning and disinfecting agents used on this lighting system must be certified by their manufacturer to\be compatible with the following materials: polycarbonate, polyetherimide, santoprene.Do not spray any cleaning product directly onto the lighthead or any system components.Dampen a soft cloth with the cleaning solution and wring out the excess moisture.Do not bump lightheads into walls or other equipment." steris counseled user facility personnel on the proper use, operation and cleaning practices for the harmonyair surgical light.No additional issues have been reported.

• Brand Name: HARMONYAIR G-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: 16727145
• Report Number: 1043572-2023-00086
• Device Sequence Number: 7190957
• Product Code: FSY
• UDI-Device Identifier: 00724995192372
• UDI-Public: 00724995192372
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/12/2023

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: LGH36
• 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: 03/14/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2018
• 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