MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY AMSCO LD202 IN-CEILING LIGHTING SYSTEM

Model Number	LD202
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the lighting system and found the orbis lighthead board assembly to be burned and was emitting the smell of smoke.The technician replaced the lighthead board assembly, tested the lighting system, confirmed it to be operating according to specifications, and returned it to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that prior to the start of a patient procedure smoke was observed emitting from their amsco ld202 in-ceiling lighting system.The patient was transferred to a different room and the procedure was completed successfully.No report of injury or procedure delay.

• Brand Name: AMSCO LD202 IN-CEILING LIGHTING SYSTEM
• Common Device Name: LIGHTING SYSTEM
• 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: 15852524
• Report Number: 1043572-2022-00085
• Device Sequence Number: 12360570
• Product Code: KZF
• UDI-Device Identifier: 00724995161286
• UDI-Public: 00724995161286
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: LD202
• Device Catalogue Number: P141211221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown