MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; SURGICAL LIGHTING SYSTEM

Model Number	M-SERIES SURGICAL LIGHTING SYSTEM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the plastic knuckle cover from their harmonyair m-series surgical lighting system detached and fell into the sterile field subsequently contacting the patient.The sterile field was reestablished, and the patient procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
A steris service technician inspected the harmonyair m-series surgical lighting system and found the screw that holds the cover in place was still attached to the lighting system along with a small ring of plastic around the screw.This type of damage is indicative of the light head impacting other equipment.Additionally, the steris technician removed the screw and ring of plastic and observed residual liquid under the ring.The liquid appeared to be a cleaning/disinfecting agent.The exposure to incompatible cleaning/disinfecting agent(s) can cause embrittlement/weaking of the polymer from which the cover is manufactured.The residual liquid observed can be attributed to improper cleaning practices by user facility personnel.The steris technician replaced the knuckle cover, tested the surgical lighting system and confirmed the unit to be operating properly.The operator manual states (1-4), "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." the operator manual further states (6-2), "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, touch panel control unit (tpcu) or any system components.Clean tpcu with a clean, lint-free cloth dampened with 90% isopropyl alcohol.For other system components, dampen a clean, soft cloth with the cleaning solution and wring out the excess moisture." a steris account manager performed in-service training on the proper use and operation for the harmonyair m-series surgical lighting system, specifically not bumping the light into other equipment, and the importance of following proper cleaning practices.The steris service technician returned the lighting system to service and no additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: HARMONYAIR
• Common Device Name: SURGICAL LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION; 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: 18127108
• Report Number: 1043572-2023-00162
• Device Sequence Number: 6349006
• Product Code: FSY
• UDI-Device Identifier: 00724995191436
• UDI-Public: (01)0072499519143611)161206(21)ORAPAR948036432
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/13/2023

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: M-SERIES SURGICAL LIGHTING SYSTEM
• Device Catalogue Number: LM02
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2016
• 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