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U.S. Department of Health and Human Services

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

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STERIS CORPORATION - MONTGOMERY HARMONY LC SURGICAL LIGHT Back to Search Results
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2018
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the harmony lc surgical light and was unable to find any evidence of the oil-like substance. The technician found the surgical light to be operating according to specification however, he noticed the plastic covers were missing on the joints of the lighting system. While onsite the technician ordered new plastic covers for the harmony surgical light for the biomed department to replace. The root cause of the reported event can most likely be attributed to residual cleaning solution as there is no oil or other fluid utilized in the manufacturing of the harmony lc surgical light. The harmony lc surgical light operator manual (pg 31) states: "4. 2 general cleaning/disinfecting procedure: thoroughly wipe the areas to be cleaned. Rinse all surfaces with a clean soft cloth wipe and clear water. Wipe all surfaces dry with a clean dry soft cloth. " the harmony lc surgical light was installed in (b)(6) 2008 making the unit approximately 10 years old and is not under steris contract agreement for preventive maintenance activities. The facilities biomed department is responsible for all maintenance activities. The technician counseled the facility's biomed department on the proper use and maintenance of the harmony lc surgical light specifically, proper cleaning techniques. No additional issues have been reported.
 
Event Description
The user facility reported an oil-like substance dripped from their harmony lc surgical light onto the surgical table during a patient procedure. No report of injury, procedure delays or cancellations. The procedure was completed successfully.
 
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Brand NameHARMONY LC 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
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key8232653
MDR Text Key132573343
Report Number1043572-2019-00006
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 01/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2018
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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