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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL ILLUMINATION INTRNATION INC. MI-15 (CENTURION EXCEL) SUGICAL LIGHT CENTURY CENTURION

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MEDICAL ILLUMINATION INTRNATION INC. MI-15 (CENTURION EXCEL) SUGICAL LIGHT CENTURY CENTURION Back to Search Results
Model Number 021514
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
The arm assembly from customer complaint (#(b)(4)) was received and identified as a sigle 21st century centurion light system (model 021514, s/n: (b)(4)). The unit was hung and visually inspected as a system. After we made out initial visual observations, we performed an in-depth analysis on the failure. The arm support fitting ((b)(4)) was identified as the failed component. We inspected the component at the break and found no evidence of porosity or irregular material flow in the area. In our analysis we observed surface damage consisting of deep circular gouges in the area under the nut attached to the coupling bolt. This would be indicative of an overtightened condition which would stress the casted aluminum tangs to a point of failure. We have witnessed this before when a customer attempted to increase the friction level of the suspension arm to minimize horizontal drift. However, we could not definitely prove this theory in that we only observed the visual incongruity while the stress fractures in the component were not readily apparent. Note: this report is late because it was sent to the test emdr instead of production.
 
Event Description
On may 17th an incident was reported to medical illumination regarding century centurion light system arm that had broken and grazed the doctors shoulder. We contacted the facility and spoke with the doctor to see if any injuries occured. He stated, no injuries to report.
 
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Brand NameMI-15 (CENTURION EXCEL) SUGICAL LIGHT
Type of DeviceCENTURY CENTURION
Manufacturer (Section D)
MEDICAL ILLUMINATION INTRNATION INC.
547 library street
san fernando CA 91340
Manufacturer (Section G)
MEDICAL ILLUMINATION INTRNATION INC.
547 library street
san fernando CA 91340
Manufacturer Contact
robert hess
547 library street
san fernando, CA 91340
8188383025
MDR Report Key8614072
MDR Text Key145946867
Report Number2028295-2018-00006
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K930897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 06/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number021514
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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