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

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the lighting system and found the side of the light head cover was broken off with the screws still in place.The root cause for the event is likely attributed to impact with another hard object.The steris harmony led operator manual states (1-4) "do not bump light heads into walls or other equipment." the led surgical lighting system was installed on 8/27/2014.The unit is not under a steris service agreement, and it is not known when or by whom the last preventive maintenance was performed.It was reported a replacement light head cover was installed and inspected.The steris service technician counseled user facility personnel on proper use of the lighting system, specifically to be careful to not impact the light head with other hard objects.No additional issues have been reported.

Event Description

The user facility reported that the light head cover of a led surgical lighting system fell off during use.The cover did not enter the sterile field.There was no report of injury or procedure delay.

• 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
• MDR Report Key: 18669316
• MDR Text Key: 334973260
• Report Number: 1043572-2024-00013
• 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: 02/08/2024

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: Not provided
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2014
• 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