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

Device Problem Unexpected Shutdown (4019)

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

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite and inspected the harmony dual lc surgical lighting system and found that the lighthead control board and the board to lamp wire harness were damaged resulting in the reported event.The technician replaced the damaged components, tested the unit, confirmed it to be operating according to specification and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure one of the lightheads went out and a burning smell was emitting from their harmony dual lc surgical lighting system.The procedure was completed successfully using another functioning lighthead.No report of injury.

• Brand Name: HARMONY LC 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: 15777332
• MDR Text Key: 304413188
• Report Number: 1043572-2022-00082
• Device Sequence Number: 1
• Product Code: FTD
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• 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: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2010
• 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