MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY LD202 SURGICAL LIGHT

Device Problem Smoking (1585)

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

Event Date 05/15/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility reported that staff had finished using the room and tried to shut off the surgical light however they were unable to do so thus causing the light to overheat.A steris service technician inspected the surgical light and found damage on the printed circuit board (pcb) assembly.The pcb assembly is being returned to steris for evaluation.The technician replaced the pcb assembly, tested the light for proper operation and returned it to service.No additional issues have been reported.The surgical light was manufactured in 2002 and is serviced and maintained by the user facility.

Event Description

The user facility reported that their surgical light began to emit smoke.No injuries were reported.

Manufacturer Narrative

The printed circuit board assembly was returned to steris for evaluation.Upon evaluation of the circuit board, it was determined that a relay contact was stuck in the closed position which caused the reported smoke observed by user facility staff.The circuit board was approximately 14 years old at the time of the reported event.

• Brand Name: LD202 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5706895
• MDR Text Key: 47699138
• Report Number: 1043572-2016-00052
• Device Sequence Number: 1
• Product Code: KZF
• 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,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• 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
• Date Manufacturer Received: 05/15/2016
• 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
• Patient Sequence Number: 1