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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY SQ-240 SURGICAL LIGHT

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STERIS CORPORATION - MONTGOMERY SQ-240 SURGICAL LIGHT Back to Search Results
Device Problems Device Emits Odor (1425); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/13/2016
Event Type  No Answer Provided  
Manufacturer Narrative

Contrary to the reported smoke emitting from the wall control board a plume of vapor emitted. The surgical light is approximately 16 years old and is serviced and maintained by user facility personnel. A letter of obsolescence was issued in 2010 for the sq-240 lighting system. Replacement components are no longer manufactured due to the obsolescence. Facility personnel stated that the wall controller began to smoke; facility personnel dispatched the fire department. The reported event occurred during the start of a patient procedure which was subsequently cancelled. No report of injury. A steris service technician arrived on site to inspect the surgical light and wall controller subject of the reported event. During discussion with facility personnel the technician determined that the wall controller had a capacitor that blew causing an electrical burning smell identified during the event. The facility's biomedical technician replaced the wall controller prior to the steris service technicians arrival. The wall controller and surgical light were found to be operating properly and were returned to service. The reported smoke observed by 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. 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. The wall controller for the light system is located outside the area that is considered an oxygen rich environment.

 
Event Description

The user facility reported the wall controller to their surgical light made a "popping noise" followed by a burning smell.

 
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Brand NameSQ-240 SURGICAL LIGHT
Type of DeviceSURGICAL 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
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key6001163
MDR Text Key57090552
Report Number1043572-2016-00081
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2016
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?
Event Location No Information
Date Manufacturer Received09/13/2016
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

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