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

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the harmony led surgical lighting system and found that the cover had been damaged.This is indicative of facility personnel bumping the lighthead into other pieces of equipment.The harmony led surgical lighting system operator manual states (1-4), "caution - possible equipment damage hazard: (continued) 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 lighthead cover, tested the lighting system, confirmed it was operating according to specifications, and returned it to service.A steris account manager offered in-service training on the proper use and operation of the harmony led 585 surgical lighting system, specifically ensuring to not bump lightheads into walls or other equipment; however, the user facility declined.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure one of the plastic covers from their harmony led 585 surgical lighting system detached and fell entering the sterile field.A procedure delay occurred as the sterile field was re-established.The procedure was completed successfully.No report of injury.

• 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: 11667591
• MDR Text Key: 247691375
• Report Number: 1043572-2021-00022
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• 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: 03/15/2021
• 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