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

Device Problem Device Fell (4014)

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

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the harmony led surgical light.The technician was informed that the facility's biomed department inspected the light and found that the c-clip had been removed by the facility, causing the light head cover to fall and the reported event to occur.The c-clip is a component that holds the light head cover in place.While onsite the technician replaced the surgical lights light head and c-clip, tested the unit, and found it to be operating according to specification.The surgical light was returned to service.The harmony led surgical light was installed in april 2009 making the light approximately 10 years old and is not under steris service agreement for maintenance activities.The facility's biomed department is responsible for all maintenance activities.A steris account manager will offer in-service training on the proper use and maintenance of the harmony led surgical light.No additional issues have been reported.

Event Description

The user facility reported that a light head cover had fell from the suspension arm of their harmony led surgical light.The event occurred between a case when the employee was cleaning the or getting ready for the following case.No report of injury or procedure delay.

Manufacturer Narrative

A steris account manager offered in-service training on the proper use and maintenance of the harmony led surgical light; however, the user facility declined.No additional issues have been reported.

• Brand Name: HARMONY LED SURGICAL LIGHT
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 8188833
• MDR Text Key: 131383987
• Report Number: 1043572-2018-00108
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1