MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LA 500 SURGICAL LIGHT

Device Problems Loss of Power (1475); Device Stops Intermittently (1599)

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

Event Date 02/06/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that during a patient procedure their surgical light intermittently turned off.

Manufacturer Narrative

No injuries or procedural delays or cancellations were reported in association to the event.The procedure was successfully completed, without delay as the facility has 3 lighting systems and continued the procedure with the 2 remaining functional lightheads.A steris service technician arrived at the facility, inspected the lighting system and found the lamp head power connector exhibited signs of overheating.The technician replaced the lamp holder, tested the unit and confirmed the lighthead was operating according to specification.The lighting system was installed in february of 2004 and is not under steris service contract.The facility is responsible for ensuring the lighting system is properly maintained and receives the recommended preventive maintenance as outlined in the harmony la 500 dual surgical light operator manual.Section 6.2 of the operator manual states, "2.Inspect the lamps for damage or discoloration.Be sure the filament of the lamp in the secondary position is intact.Replace if necessary." no further issues have been reported.

• Brand Name: HARMONY LA 500 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: 4571986
• MDR Text Key: 18542417
• Report Number: 1043572-2015-00020
• Device Sequence Number: 1
• Product Code: FTD
• 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
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/06/2015
• 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