MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY SQ240 SURGICAL LIGHT; LIGHTING SYSTEM

Device Problem Smoking (1585)

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

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

Contrary to the reported event, the "smoke" observed by user facility personnel from the wall controller is actually vaporized contents of the electrolyte used in the capacitors located on the power control board in the wall control.The surgical light was 10 years old at the time of the event.The expected useful life of the system is 7 years under normal condition of use.A letter of obsolescence was issued in 2010 for the sq240 lighting system.Replacement components are no longer manufactured due to the obsolescence.A steris service technician arrived onsite to inspect the surgical light and wall controller subject of the reported event.During discussion with facility personnel the technician determined that one of the wall controller fuses overheated.As designed, when a capacitor fails due to overheating caused by excess current, the pressure relief vent at the top of the capacitor opens to allow the capacitor to exhaust, emitting a plume of vapor which lasts a short time and stops.The vapor is not harmful.Additionally, the outer cover of the control box is made of a 94-v0 polymer material which does not support combustion and is a standard polymer material commonly used for medically-rated equipment.The user facility removed the sq240 surgical light from service and have ordered a new surgical lighting system.No additional issues have been reported.

Event Description

The user facility reported the wall controller to their sq240 surgical light was emitting smoke.Power to the wall controller was shut off by facility personnel.A patient was present during the time of the reported event; however, no injury, procedure delay or cancellation occurred.The procedure was completed successfully.

• Brand Name: SQ240 SURGICAL LIGHT
• 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: 7466443
• MDR Text Key: 107197668
• Report Number: 1043572-2018-00032
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2018
• 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