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 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the lighting system and found that the screw insert for the cover had been damaged allowing the cover to detach and the reported event to occur.Additionally, the technician observed scratches and cracks on the other lighthead.The observed damage to the lighting system is indicative of facility personnel bumping the lighthead into other pieces of equipment.The operator manual states (1-4), "do not bump light heads into walls or other equipment." the technician completed the necessary repairs, tested the lighting system, confirmed it was operating according to specification, and returned it to service.A steris account manager offered in-service training on the proper positioning and suspension of lights heads, specifically to not contact other equipment that may be nearby; steris is awaiting the user facility's response.No additional issues have been reported.

Event Description

The user facility reported that one of the cover halves of their harmony led 585 surgical lighting system fell entering the sterile field.As the sterile field became re-established a procedure delay occurred.The procedure was completed successfully.No report of injury.

Manufacturer Narrative

A steris account manager offered in-service training on the proper positioning and suspension of lights heads, specifically to not contact other equipment that may be nearby; however, the user facility declined.No additional issues have been reported.

• 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
• MDR Report Key: 11245876
• MDR Text Key: 259339225
• Report Number: 1043572-2021-00004
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1