MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LED 385 SURGICAL LIGHT

Device Problem Component Falling (1105)

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

Event Date 04/13/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Steris personnel identified that this harmony led 385 light is manufactured by a third party.A steris district service manager was notified that the light fell from the support.It was identified that a set screw to hold the light in place was not properly attached, causing the light to fall.The facility stated the light was easily moved to the floor and had no impact on the patient procedure.Steris notified the third party of the issue that was found.The harmony led 385 light was installed by a third party on 11/21/2013 and this was the first reported event of this type.The technician and user facility personnel inspected all harmony led 385 lights in the facility and found one additional set screw to be missing out of 170 lights.The installation instructions state on page 4-9 "use drill to make 7mm diameter hole on tube side near m8 nut welded on plate hub.Insert m8 x 35 screw supplied with nut until conical point presses against the hole previously obtained in anchoring tube." steris is not under contract for preventative maintenance of the harmony led lights at the user facility.The steris preventative maintenance schedule states on page 6-2 "check for proper installation 2x per year." the steris dsm notified the facility of the proper maintenance practices for the light.

Event Description

The user facility reported that their harmony led 385 light fell from the ceiling.No injury, procedural delay, or cancellation was reported.

• Brand Name: HARMONY LED 385 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: 5647720
• MDR Text Key: 45101570
• Report Number: 1043572-2016-00042
• Device Sequence Number: 1
• Product Code: KZF
• 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
• Report Date: 05/11/2016

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 05/11/2016
• 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