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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LC500 SURGICAL LIGHTING SYSTEM

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STERIS CORPORATION - MONTGOMERY HARMONY LC500 SURGICAL LIGHTING SYSTEM Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem Injury (2348)
Event Date 01/29/2018
Event Type  malfunction  
Manufacturer Narrative
The surgical lighting system was installed in november of 2006 and is approximately 11 years old. The lighting system is not under steris service contract for maintenance, all maintenance is performed by a third party service provider. A steris service technician arrived on-site to inspect the surgical lighting system. The technician found that the screw and nut that secure the yoke sleeve in place on the springarm were missing allowing the yoke sleeve to slide up on the springarm and expose the securing key. The absence of the yoke sleeve screw allowed for the securing key to fall out of position resulting in the reported event. As the yoke and lighthead fell, the 2nd lighthead's spring arm retracted due to the absence of weight and made contact with the ceiling of the or room. This impact caused particulates from the ceiling to fall into a second employee's eyes. The user facility stated that the second employee utilized the eye-wash station to clear their eyes. The technician replaced the necessary components, tested the surgical lighting system, and found it to be operating according to specification. This event can be attributed to improper maintenance of the harmony lc500 lighting system by the third party service provider specifically that the screw and nut which holds the yoke sleeve in place were missing. The technician counseled the user facility of the importance of proper maintenance of the unit. The user facility will contact the third party provider to ensure proper maintenance is performed on the subject surgical lighting system. No additional issues have been reported.
 
Event Description
The user facility reported prior to a procedure, during room set-up that one of the lightheads from the lc500 lighting system detached injuring an employee's arm. The employee sought and received medical treatment and returned back to work. The intended procedure was rescheduled for another or room.
 
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Brand NameHARMONY LC500 SURGICAL LIGHTING SYSTEM
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 Key7303863
MDR Text Key101493900
Report Number1043572-2018-00020
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 02/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2018
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? No
Event Location No Information
Date Manufacturer Received01/29/2018
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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