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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY EXAMINER 10 SURGICAL LIGHT
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STERIS CORPORATION - MONTGOMERY EXAMINER 10 SURGICAL LIGHT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 08/15/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician has requested to inspect the examiner 10 surgical light subject of the event; steris is awaiting the user facility's response.The light was installed in 1995 making it approximately 24 years old at the time of the reported event and is not under steris service agreement.The user facility is responsible for all maintenance activities.A follow-up mdr will be submitted when additional information becomes available.
 
Event Description
The user facility reported to (b)(4) that a patient obtained a burn during a procedure while using their examiner 10 surgical light.Medical treatment was administered.
 
Manufacturer Narrative
A steris service technician arrived onsite to inspect the examiner 10 surgical light and found the light to be operating properly.It is unknown if any repairs to the lighting system had been completed prior to our inspection.The reported event occurred in (b)(6) 2019; however, steris was not notified until (b)(6)2019.The expected useful life of the light is 10 years and at the time of the reported event the light was approximately 24 years old.The user facility has removed the light from service.A review of complaints indicates this to be an isolated event.No additional issues have been reported.
 
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Brand Name
EXAMINER 10 SURGICAL LIGHT
Type of Device
SURGICAL LIGHT
Manufacturer (Section D)
STERIS CORPORATION - MONTGOMERY
2720 gunter park drive east
montgomery AL 36109
MDR Report Key9491275
MDR Text Key209025241
Report Number1043572-2019-00105
Device Sequence Number1
Product Code KZF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Date Manufacturer Received11/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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