CENTURION EXCEL
Received Jul 22, 2015 · Event occurred Jun 12, 2012
Report 2028295-2015-00001 · MDR key 4943577
Device
Generic name
Minor Surgical Light
Manufacturer
Medical Illumination International, Inc.Model number
061514Product problems
- Break
- Off-Label Use
Patient
Not reported
- Injury
Narrative
Additional Manufacturer Narrative
THE LIGHT AND ARM WERE RETURNED TO THE FACTORY FOR ANALYSIS. UPON ARRIVAL, THE ARM SUPPORT FITTING WAS INSPECTED FOR POROSITY AND/OR VOIDS IN THE MATERIAL. NO ANOMALIES IN THE MATERIAL WERE FOUND. THE ARM SUPPORT MATERIAL WAS ALSO IDENTIFIED THAT IT WAS THE SPECIFIED MATERIAL. ADDITIONAL TESTING OF NEW PRODUCT WAS PERFORMED TO VERIFY PRODUCTION PARTS PERFORMED AS DESIGNED. UNABLE TO DETERMINE EXACT CAUSE OF THIS FAILURE. WILL MONITOR FOR ANY FUTURE OCCURRENCES. THE ARM SUPPORT COMPONENT WAS PUT UNDER TEST WITH A 6X LOAD TO CONFIRM THE INITIAL LOAD HANDLING CAPACITY. THIS TEST WAS CONFIRMED AS POSITIVE AND THE CASE WAS CLOSE WITH THE REPLACEMENT OF THE LIGHT ON (B)(4) 2012.
Description of Event or Problem
ON (B)(6) 2012 AN INCIDENT WAS REPORTED TO MEDICAL ILLUMINATION REGARDING AN EXCEL LIGHT ARM SUPPORT FITTING FRACTURED CAUSING THE LIGHT TO FALL HITTING THE DOCTOR ON HIS BACK. THE LIGHT FELL WHEN BEING REMOVED.