MAUDE Adverse Event Report: STERIS CORPORATION HARMONY LED; LIGHT, SURGICAL, CEILING MOUNTED

Device Problem Corroded (1131)

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

Event Date 09/27/2016

Event Type  malfunction  

Event Description

This happened in our surgical operating room.Steris harmony led ceiling mounted surgical lights found to be rusted.Cleaning solution is running down the arm and getting trapped under the service collar that covers the break screws near the head light.These fluids are rusting the lights.

• Brand Name: HARMONY LED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 6066270
• MDR Text Key: 58736683
• Report Number: 6066270
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2016,10/13/2016

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1