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

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the sq240 surgical lighting system and found that a blown fuse within the wall control to the lighting system and that the wall control was damaged.The blown fuse caused the wall control to short, and the reported event to occur.The technician made the necessary repairs, tested the unit, confirmed it was operating according to specifications, and returned the unit to service.The surgical light was 24 years old at the time of the event.The expected useful life of the system is 7 years under normal condition of use.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure their sq240 surgical lighting system began emitting smoke.The procedure was completed successfully.No report of injury or procedure delay.

• 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: 13979903
• MDR Text Key: 298240810
• Report Number: 1043572-2022-00024
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/01/2022
• 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