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

Model Number	E-Series
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that one of the lightheads detached from the spring arm of their harmonyair e-series surgical lighting system.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the lighting system and found that the snap ring had become dislodged from where installed and the stop pin was broken.Due to the damage, the technician made the necessary repairs, tested the lighting system, confirmed it to be operating according to specification, and returned it to service.The observed damage to the pin is indicative of the lighthead being subject to a high load of impact by user facility personnel.The technician counseled the user facility on the proper use and operation of the harmonyair e-series surgical lighting system.No additional issues have been reported.

• 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: 13895676
• Report Number: 1043572-2022-00021
• Device Sequence Number: 11780810
• Product Code: FSY
• UDI-Device Identifier: 00724995172749
• UDI-Public: 00724995172749
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: E-Series
• Device Catalogue Number: LEH02INNDT
• 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: 02/23/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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