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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the harmony led 585 surgical lighting system and found that multiple covers to the lighting system were cracked, and the joint cover was missing.This is indicative of facility personnel bumping the lighting system into other pieces of equipment.The harmony led 585 surgical lighting system operator manual states (5-7), "caution - possible equipment damage hazard: do not bump lightheads into walls or other equipment.Always use handles when positioning lighthead during surgical procedures, or when cleaning or servicing the lighting system.Do not bump lightheads into walls or other equipment.Always use handles when positioning lighthead during surgical procedures, or when cleaning or servicing the lighting system." the technician replaced the damaged covers and missing joint cover, tested the lighting system, confirmed it to be operating according to specification, and returned it to service.The technician counseled user facility personnel on the proper use and operation of the harmony led 585 surgical lighting system, specifically the importance of not bumping the lighting system into other pieces of equipment.No additional issues have been reported.

Event Description

The user facility reported that a plastic piece of the cover to their harmony led 585 surgical lighting system fell contacting a patient.The plastic was removed, and the sterile field was re-established resulting in a procedure delay.The procedure was completed successfully.Antibiotics were prescribed to the patient.

• Brand Name: HARMONY LED 585 SURGICAL LIGHTING SYSTEM
• Type of Device: 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: 15252875
• MDR Text Key: 298168257
• Report Number: 1043572-2022-00054
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/18/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2013
• 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