MI-1000
Received May 14, 2019 · Event occurred Oct 25, 2017
Report 2028295-2018-00001 · MDR key 8609538
Device
Generic name
Minor Surgical Light
Manufacturer
Medical Illumination International Inc.Model number
061515-VProduct problems
- Fracture
- Fracture
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE PRODUCT FROM CUSTOMER COMPLAINT # (B)(4) WAS RECEIVED AND AN INVESTIGATION WAS INITIATED. A VISUAL INSPECTION SHOWED THAT THE ARM SUPPORT FITTING (P/N 1002036) FAILED WITH NO OTHER APPARENT DAMAGE. WE PERFORMED A STRUCTURAL ANALYSIS IAW FAILURE ANALYSIS OF THE MI-1000 DATED 07/16/2015. WE REVIEWED THE POROSITY OF THE MATERIAL AND FOUND NOTHING IRREGULAR. THE PRODUCT WAS REBUILT SO WE COULD PERFORM CAPACITY TESTING. THE UNIT PASSED A 6X LOAD TEST FOR 24+ HOURS. WE WERE UNABLE TO DETERMINE THE REASON FOR THE FAILURE. THE POTENTIAL FOR MISUSE IS ALWAYS PRESENT BUT WE WERE UNABLE TO DEFINITIVELY TIE THIS FAILURE TO ANY ABUSE OR MISUSE. THIS BRAKEAGE IS UNUSUAL AS THIS WAS THE ONLY REPORTED BRAKEAGE OF THIS TYPE OF THE (B)(4) ARMS SHIPPED IN 2015. NOTE: THIS REPORT IS LATE BECAUSE IT WAS SENT TO THE TEST EMDR INSTEAD OF PRODUCTION.
Description of Event or Problem
ON (B)(6) 2017 AN INCIDENT WAS REPORTED TO MEDICAL ILLUMINATION REGARDING AN MI-1000 ARM SUPPORT FITTING FRACTURED CAUSING THE LIGHT TO FALL. NO INJURIES REPORTED.