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

Model Number	E-SERIES
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris surgical services specialist arrived onsite to inspect the harmonyair e-series surgical lighting system and confirmed the dual monitor yoke had detached.The dual monitor yoke associated with this event was returned to the steris montgomery facility and has been submitted for engineering evaluation.The technician replaced the dual monitor yoke, tested the lighting system, confirmed it to be operating according to specification, and the lighting system was returned to service.A follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported that during a patient procedure one of the dual monitor yokes to their harmonyair e-series surgical lighting system separated from the spring arm and was hanging by the lighting system cables.User facility personnel stabilized the monitors on a stand resulting in a procedure delay.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The results of the evaluation of the returned device concluded that the cause of the reported yoke detachment could not be determined.The unit is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities, steris will continue to monitor for similar events.

• Brand Name: HARMONYAIR E-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: 15771929
• Report Number: 1043572-2022-00080
• Device Sequence Number: 12417585
• Product Code: FSY
• UDI-Device Identifier: 00724995175542
• UDI-Public: 00724995175542
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 11/10/2022

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: E-SERIES
• Device Catalogue Number: LES11IN01
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2020
• 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