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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LA 500 SURGICAL LIGHT

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STERIS CORPORATION - MONTGOMERY HARMONY LA 500 SURGICAL LIGHT Back to Search Results
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Information (3190)
Event Date 07/24/2017
Event Type  malfunction  
Manufacturer Narrative
The plastic cover did not contact the patient or surgical staff. No injuries occurred as a result of the event. A steris service technician arrived onsite to inspect the surgical lighting system and found that both screws were still intact with the plastic yoke cover assembly. The technician noted that the customer has been using cleaning product that is corrosive to the plastic coverings. The technician replaced the broken plastic yoke cover components and returned the surgical lighting system to service. The technician reinforced the importance of using proper cleaning products when using the surgical lighting system. The harmony la 500 surgical lighting system operator manual states (p. 1-3), "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". The surgical lighting system was installed in the customer's location in 2008 and is under steris service agreement. No additional issues have been reported.
 
Event Description
The user facility reported that the plastic yoke cover on their surgical lighting system fell during a patient procedure. Report of procedure delay as the sterile field was re-established.
 
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Brand NameHARMONY LA 500 SURGICAL LIGHT
Type of DeviceSURGICAL 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 Key6814511
MDR Text Key83630637
Report Number1043572-2017-00059
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/24/2017
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

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