MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LED585 SURGICAL LIGHTING SYSTEM

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

A steris account manager arrived onsite and confirmed that the cover had detached from the lighting system.The account manager observed that the cover had been damaged which is indicative of facility personnel bumping the lighthead into other pieces of equipment.It was also noted that multiple lightheads were damaged within other operating rooms at the facility.The harmony led surgical lighting system operator manual states, "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." the user facility elected to replace the covers themselves and returned the lighting system to service.The account manager counseled the user facility on the proper use and operation of the harmony led surgical light, including the importance of not bumping the light into other equipment.No additional issues have been reported.

Event Description

The user facility reported that a plastic yoke cover from their harmony led585 surgical lighting system detached and fell during a patient procedure.The cover did not impact the sterile field.A procedure delay occurred while facility personnel evaluated the situation, and the procedure was completed successfully.No report of injury.

• Brand Name: HARMONY LED585 SURGICAL LIGHTING SYSTEM
• Type of Device: LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 9948125
• MDR Text Key: 206782786
• Report Number: 1043572-2020-00020
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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