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

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the harmony vled surgical light and identified rust and paint chipping on the spring arm.The unit was installed in 2011 making it approximately 8 years old and is not under steris service agreement.The user facility is responsible for all maintenance activities.Based on the technician's inspection, the reported event is attributed to improper use and maintenance of the surgical light.A combination of impact damage to the lighthead and improper cleaning techniques subsequently caused the rust and paint chipping to occur over time.The harmony vled surgical light operator manual states on page 1-3, "caution - possible equipment damage: do not bump lightheads into walls or other equipment." the harmony vled surgical light operator manual states on page 6-1, "caution - possible equipment damage hazard: always follow manufacturer instructions for concentrations and use of cleaning products.Do not spray any cleaning product directly onto the lighthead, modem chassis, or any system components.Dampen a soft cloth with the cleaning solution and wring out the excess moisture." a steris account manager will offer in-service on the proper use and maintenance of the harmony vled surgical light, specifically not bumping the lighthead into other equipment and proper cleaning techniques.The user facility has requested that the spring arm be replaced.Once the spring arm is replaced, the unit will be placed back in-service.

Event Description

The user facility reported that during a patient procedure a piece of paint fell from their harmony vled surgical light, entering the sterile field.The sterile field was re-established, and the procedure was completed successfully.No report of injury.

• Brand Name: HARMONY VLED 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8719110
• MDR Text Key: 150884073
• Report Number: 1043572-2019-00048
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• 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: 06/19/2019

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: 05/23/2019
• Initial Date FDA Received: 06/20/2019
• 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