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

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

No report of procedure delay or cancellation.Prior to the reported event, the plastic yoke cover was being held on with a piece of tape.The surgical light is serviced and maintained by the facility's biomedical department.The facility's biomedical technician inspected the light and replaced the yoke cover.Following the biomedical technicians repair, a steris service technician arrived onsite.The steris technician inspected the surgical light and found the unit to be operating properly; no issues were noted.A review of service history confirms that steris has not performed service or maintenance on the surgical light subject of the reported event.This is the only time steris has been contacted to service the lighting system.The event may be attributed to unknown damage that the lighthead sustained prior to the reported event.The operator manual states (pp.1-4), "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.".

Event Description

The user facility reported that during a patient procedure, the plastic yoke cover detached from the surgical light and fell into the sterile field.No report of injury and the procedure was completed successfully.

• Brand Name: HARMONY LED585 SURGICAL LIGHT
• Type of Device: SURGICAL LIGHT
• 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: 7119098
• MDR Text Key: 95794625
• Report Number: 1043572-2017-00082
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2017
• 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