MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LC SURGICAL LIGHTING SYSTEM

Device Problem Power Problem (3010)

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

Event Date 04/13/2022

Event Type  malfunction  

Event Description

The user facility reported via a cofepris report that their harmony lc surgical lighting system is not operating properly.A procedure delay was reported.No report of injury.

Manufacturer Narrative

A steris representative has made multiple attempts to contact the user facility to obtain additional information regarding the reported event and to inspect the surgical lighting system subject of the reported event.However; the user facility has not responded to steris.The serial number entered in the report does not correlate with the serialization format utilized by steris (804sm155001491).Steris no longer manufactures the harmony lc surgical lighting system and discontinued sales of the device in december 2012.From the information captured in the cofepris report, it appears the issue described indicates that one of the lightheads in the operating room was not providing illumination when powered on and that the movement of the lightheads indicates they are not staying in place (drifting).The lack of illumination could be attributed to a bulb requiring replacement, wear on the lampholder assembly, wiring issues or other power delivery components.The drifting of the lightheads as described could be attributed to brake screws requiring adjustment and/or replacement.Steris has not been able to inspect the harmony lc surgical lighting system therefore we cannot confirm the reported event information as described in the cofepris report.The harmony lc surgical lighting system operator manual is provided with every harmony lc surgical lighting system sold.This manual contains information regarding the correct part number for replacement lamps, instructions on determining when a lamp has failed and the correct process for replacement.This manual also documents steris' recommended preventive maintenance activities including inspecting/replacing lamps, lamp change mechanism, lighthead/wiring deterioration, and checking the suspension system for drift.The manual also documents an "operator troubleshooting" section which identifies potential problems and the possible cause and/or correction.A follow-up report will be submitted should additional information be obtained.No additional issues have been reported.

Manufacturer Narrative

Steris was able to obtain access to the harmony lc lighting system subject of the reported event.During inspection of the lighting system, steris was able to confirm the correct serial number of the unit ((b)(6)).The lighting system has been in service for approximately 11 years and is not serviced or maintained by steris.Steris inspected the lighting system and found damaged components in both lightheads and within the wall control.The unit was all missing plastic covers from the suspension arms.Due to the damaged components, the lamps (bulbs) on one of the lightheads was not receiving power.The damage was determined to be due to the lighting system not receiving proper preventive maintenance/service.The customer's biomed engineering department was made aware of the status of the unit and steris provided recommendations for correcting the observed damage necessary to restore the unit to proper operation.No additional issues have been reported.

• Brand Name: HARMONY LC SURGICAL LIGHTING SYSTEM
• Type of Device: 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: 14569630
• MDR Text Key: 301033737
• Report Number: 1043572-2022-00040
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• 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: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2011
• 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