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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR M5 SURGICAL LIGHT

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STERIS CORPORATION - MONTGOMERY HARMONYAIR M5 SURGICAL LIGHT Back to Search Results
Device Problems Contamination (1120); Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite to inspect the surgical light and found that the top half of the lighthead yoke cover was detached from the lighting system. The screw and the bottom half of the lighthead yoke cover were still in place. The technician observed cracks and abrasions in the top half of the head yoke cover. The harmonyair surgical lighting system m series operator manual states (pg. 1-4), "do not bump lightheads into walls or other equipment. Always use handles or gripping surface when positioning lighthead during surgical procedures, or when cleaning or servicing the lighting system". The technician replaced the cover, confirmed the unit to be operating properly, and returned the unit to service. The reported event can be attributed to impact damage due to the lighthead bumping into other equipment or light heads. A steris account manager will offer in-service training to the facility on the proper use and operation of the harmonyair m5 surgical light. No additional issues have been reported.

 
Event Description

The user facility reported that during patient set up a plastic cover detached from the surgical light and fell, compromising the sterile field. The sterile field was re-established, and the procedure was completed successfully. No report of injury.

 
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Brand NameHARMONYAIR M5 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 Key7891425
MDR Text Key120970018
Report Number1043572-2018-00074
Device Sequence Number1
Product Code FSY
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,Followup
Report Date 09/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
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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