MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LED 585 SURGICAL LIGHT

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 02/23/2016

Event Type  No Answer Provided  

Manufacturer Narrative

No injury was reported.The user facility stated the harmony led 585 light head contacted the monitor arm and scratched against a screw which dislodged a paint chip.The paint chip fell onto the sterile drapes, resulting in the need to replace the drapes.A steris service technician arrived on site, inspected the unit, and confirmed the paint chip was caused by the light impacting the monitor arm.A user facility biomed technician installed a rubber bumper on the monitor arm to prevent further issues.No additional issues have been reported with the harmony led 585 light.The operator manual states on pg.1-4 "do not bump light heads into walls or other equipment.Always use handles when positioning light head during surgical procedures, or when cleaning or servicing the lighting system.".

Event Description

The user facility reported that during preparation for a patient procedure, a paint chip fell off of the harmony led 585 light onto the sterile drapes.The start of the procedure was delayed.

• Brand Name: HARMONY LED 585 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: 5520593
• MDR Text Key: 41010935
• Report Number: 1043572-2016-00027
• 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
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• 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