MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LED 785 SURGICAL LIGHTING SYSTEM

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived at the user facility following the reported event to inspect the lighting system.The technician identified that the plastic cover was brittle and cracking in the area where the plastic cover halves are secured over the spring arm with screws.The technician's evaluation identified that it was from this brittle, compromised area of the plastic covering that a small piece detached and fell into the sterile field.The technician replaced the light head cover, tested the surgical light and confirmed the unit was operating according to specification.Steris's investigation determined that the most likely cause of the lighting cover damage was the use of off-label cleaning agents and cleaning practices performed by the user facility.Specifically, excess cleaning solution infiltrating the light's screw housing and degrading the mount.The harmony led 585 operator manual (6-1) states, "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," and (1-3) states, "caution: possible equipment damage use of any disinfectant solution other than those listed below may cause discoloration or deformation on the lens surface: germicidal surface wipes disinfecting/deodorizing/cleaning wipes.Cleaning solutions other than those listed have not been tested for compatibility or effectiveness.Always follow manufacturer instructions for concentrations and use of cleaning products.Use only recommended cleaning/disinfecting and/or anti-static agents on this light.Some degree of staining, pitting, and/or discoloration could occur if a phenolic-, iodophor-, or glutaraldehyde-based disinfectant is used on the surfaces of this light.Also, use of alcohol or aerosol spray cleaner/disinfectants containing a substantial amount of alcohol in the formula can damage the polycarbonate lens.".

Event Description

The user facility reported that during a patient procedure a piece of the lighting system cover detached from the surgical light and fell into the sterile field.No report of injury, procedural delay, or cancellations.

• Brand Name: HARMONY LED 785 SURGICAL LIGHTING SYSTEM
• 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: 5901429
• MDR Text Key: 53818905
• Report Number: 1043572-2016-00071
• 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: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• 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
• Date Manufacturer Received: 07/26/2016
• 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