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

Model Number	E-Series
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	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Hold r.P 10.31.2022 the user facility reported that their harmonyair e-series surgical lighthead fell.There was no one in the room at the time of the reported event.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the lighting system and found that the dowl stop pin and snap ring were bent due to high load impact allowing the lighthead to detach.The unit is not under steris service agreement; the user facility is responsible for all maintenance activities.The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned to service.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: 14956409
• Report Number: 1043572-2022-00046
• Device Sequence Number: 6906154
• Product Code: FSY
• UDI-Device Identifier: 00724995173746
• UDI-Public: 00724995173746
• 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
• Report Date (Section B): 07/08/2022

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
• Device Model Number: E-Series
• Device Catalogue Number: LES01IN01
• 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: 06/08/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2019
• 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