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U.S. Department of Health and Human Services

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

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STERIS CORPORATION - MONTGOMERY HARMONY LA 500 SURGICAL LIGHTING SYSTEM Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2022
Event Type  malfunction  
Event Description
The user facility reported that during a patient procedure one of the plastic covers from their harmony la surgical lighting system detached and fell entering the sterile field. The cover was removed from the sterile field and the sterile field was reestablished resulting in a procedure delay. The procedure was completed successfully. No report of injury.
 
Manufacturer Narrative
A steris service technician arrived onsite to inspect the harmony la surgical lighting system and found that the cover subject of the event was missing the screw which attaches it to the lighting system. The technician replaced the screw, re-installed the cover, testing the lighting system, confirmed it to be operating according to specification, and returned it to service. No additional issues have been reported.
 
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Brand NameHARMONY LA 500 SURGICAL LIGHTING SYSTEM
Type of DeviceLIGHTING SYSTEM
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 Key13506413
MDR Text Key288098766
Report Number1043572-2022-00011
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 02/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2022
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
Date Manufacturer Received01/11/2022
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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