MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY DUAL LED585 SURGICAL LIGHT

Device Problem Unintended System Motion (1430)

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

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

The user facility stated that during a patient procedure, user facility personnel attempted to adjust the height of their harmony led light spring arm, and the spring arm drifted down.The spring arm was locked in place and the procedure was completed successfully.A user facility biomed technician identified damage to the casting of the spring arm between the 20° and 30° stop.Photos of the damage were sent to steris quality personnel for review.Steris quality personnel identified that the damage found on the spring arm casting was most likely a result of improper adjustment to the stops.Steris quality also confirmed that this damage would have caused the spring arm to drift in a downward motion as described within the reported event.A steris service technician arrived on site, replaced the damaged spring arm, and confirmed the unit to be operating according to specification.The harmony led light was manufactured in 2012 and is not under steris contract for preventative maintenance services.All maintenance is performed by the user facility's biomed technician.The harmony led light operator manual states on page 4-4 "check that light does not drift when positioned.Verify overall condition of arm.Two (2) x per year." no additional issues have been reported.Steris will offer in-service training to the user facility on the proper operation and maintenance practices for the harmony led lights.

Event Description

The user facility reported their harmony led light was drifting during a patient procedure.No injury, procedure delay, or cancellation occurred as a result.

Manufacturer Narrative

Steris offered the user facility in-service training on the proper use and preventative maintenance practices for their harmony led light however the user facility declined the offer.

• Brand Name: HARMONY DUAL LED585 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: lyndsey snyder ; 5960 heisley road; mentor, OH 44060 ; 4403927386
• MDR Report Key: 6735665
• MDR Text Key: 81089885
• Report Number: 1043572-2017-00050
• 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,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2017
• 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