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

Device Problem Device Emits Odor (1425)

Patient Problem No Code Available (3191)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

User facility maintenance inspected the or and found the root cause of the burning odor to be attributed to the wall control of the sq240 surgical light.While inspecting the wall control, the user facility determined that the p6 connector, a component within the wall control overheated, causing the reported odor.User facility maintenance replaced the entire wall control and called a steris service technician to inspect the surgical lighting system to ensure the repair was made correctly.The technician examined the repair and found the lighting system to be operating according to specification and returned it to service.The surgical light was 11 years old at the time of the event.The expected useful life of the system is 7 years.No additional issues have been reported.

Event Description

The user facility reported a burning smell in the operating room during a patient procedure causing delay.The patient was moved into a different or and the procedure was completed successfully.

• Brand Name: SQ240 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7870575
• MDR Text Key: 120397265
• Report Number: 1043572-2018-00072
• 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: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• 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
• Date Manufacturer Received: 08/21/2018
• 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