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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL ILLUMINATION INTRNATION INC. CENTURION LIGHT SURGICAL LIGHT

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MEDICAL ILLUMINATION INTRNATION INC. CENTURION LIGHT SURGICAL LIGHT Back to Search Results
Model Number 021515
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2019
Event Type  malfunction  
Manufacturer Narrative
The arm support fitting specified in customer complaint (b)(4) was received in to engineering for failure analysis. The component is on a dual centurion - ceiling mount model (021515 / s/n (b)(4)). The component was visually inspected and found to have failed on the 1002036 upper tang. The wear-and-tear of the unit was deemed very high because of its age and there were also indications that the component could have exceeded its load limits. We reviewed the manufacturing date of this unit and found on similar instances of this type of failure from this date code. We did multiple cross-section cuts and can rule out porosity as a possible cause of failure. However there appeared to be stress-related factors at the breaking point. These included a slight stretching of the aluminum tang which indicates that either the arm was overly stressed by weight or the torque on the component mounting bolt. Both conditions would give the same indication at the breaking point of the 1002036. We are attributing the ultimate cause of this failure of the 1002036 as being overstressed. We speculate that this light either had an excessive load applied on the arm or that the mounting bolt was over-tighten to remove drift in the system. This is derived from the fact that the tang had signs of slight stretching at the break line which is indicative of a stress failure or an over clenched bolt.
 
Event Description
On october 7th, an incident was reported to medical illumination about a broken arm support fitting on a centurion light system. There were no injuries.
 
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Brand NameCENTURION LIGHT
Type of DeviceSURGICAL LIGHT
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 Key9271780
MDR Text Key196117223
Report Number2028295-2019-00003
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 user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number021515
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2005
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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