MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR 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	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris surgical service technician inspected the lighting system and reported the indicated yoke cover was damaged as the mounting screws and parts of the yoke cover were still attached to the lighting system.The observed damage is indicative of impact damage caused by user facility personnel bumping the lighthead into walls or other equipment.The steris technician replaced the lighthead cover and confirmed unit was operational.Lighting system was returned to service.The harmonyair m-series surgical lighting system operator manual states, "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.".A steris account manager to offer counseling on the proper use and operation of the lighting system.A follow-up mdr will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
The user facility reported the surgical lighthead cover to a harmonyair m-series surgical lighting system fell off during procedure.There was a procedure delay as the facility personnel had to reestablish the sterile field.Procedure was completed and no report of injury.
Additional Manufacturer Narrative
Steris 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 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
• MDR Report Key: 19055278
• Report Number: 1043572-2024-00019
• Device Sequence Number: 20863165
• Product Code: FSY
• UDI-Device Identifier: 00724995191566
• UDI-Public: 00724995191566
• 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): 04/05/2024

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
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2016
• 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