MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LED 585 SURGICAL LIGHT

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

A steris technician arrived onsite to inspect the led surgical lighting system and confirmed the brakes were worn out and in need of replacement.As the brakes were worn this caused a lack of brake-friction resistance resulting in the reported drift.The lighting system was installed in 2010, making it approximately 13 years old.The unit is not under steris service agreement and the user facility is responsible for all maintenance activities.The steris harmony led operator manual states (4-2) "check suspension movement- when positioned, the lighthead and monitor support arms should not drift.If binding or drifting is present in suspension movements, call your steris service representative to make adjustments." the following guidance is also included within the operator troubleshooting portion of the steris harmony led operator manual (section 7) "problem: lighthead(s) or monitor arm(s) drifts once set in position and released.Possible cause and/or correction: brake friction, weighting or tension spring adjustment incorrect- call your service representative, or - if qualified - consult section concerning suspension arm adjustments in maintenance manual, p764330-226." the root cause for the reported event is likely attributed to improper maintenance of the brakes by user facility personnel.While onsite, the steris service technician counseled user facility personnel on proper use and maintenance of the lighting system, specifically ensuring it does not drift prior to use.We are pending the customer's response on repairs to the lighting system.The lighting system remains out of service.A follow-up mdr will be submitted once additional information becomes available.

Event Description

The user facility reported that a patient received a head injury from a harmony led surgical lighting system that drifted into the adjacent mri unit.The patient sought medical assessment, but the user facility did not disclose the extent of injury or if medical treatment was administered.There was no report of procedure delay.

Manufacturer Narrative

Repairs to the harmony led surgical lighting system have been made and the room has been returned to service.In addition, the customer has been counseled on proper maintenance inspections to mitigate future issues.No additional issues have been reported.

• Brand Name: HARMONY LED 585 SURGICAL LIGHT
• Type of Device: SURGICAL LIGHT
• 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: 18624584
• MDR Text Key: 334388959
• Report Number: 1043572-2024-00009
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1