MI-1000
Received May 14, 2019 · Event occurred Nov 30, 2017
Report 2028295-2018-00002 · MDR key 8609589
Device
Generic name
Minor Surgical Light
Manufacturer
Medical Illumination Intrnation Inc.Model number
061514-VProduct problems
- Fracture
- Fracture
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
WE RECEIVED THE RETURNED LIGHT LISTED UNDER CUSTOMER COMPLAINT #(B)(4) AND IMITATED AN INVESTIGATION. THE PRODUCT WAS A MI-1000 SINGLE CEILING MOUNT. A VISUAL INSPECTION WAS PERFORMED AND OTHER THAN THE ARM SUPPORT FITTING (P/N 1002036) THERE WAS LIGHT SURFACE DAMAGE FOUND (IE: NICKS AND SCRATCHES). BECAUSE THE ARM SUPPORT FITTING (1002036) WAS TESTED SEVERAL WEEKS AGO UNDER RMA # (B)(4) FOR ANOTHER CUSTOMER COMPLAINT (#(B)(4)). THE LOAD TEST WAS NOT RUN AGAIN. WE DID CROSS-SECTION ANALYSIS ON THE FAILED SURFACES AND DID NOT SEE ANY POROSITY OR ABNORMAL MATERIAL FLOW PATTERNS. WE COULD NOT DEFINITIVELY DETERMINE THE CAUSE OF THE FAILURE. THE LIGHT SURFACE DAMAGE WAS DEEMED INCONSEQUENTIAL. THIS ARE WAS OUT OF (B)(4) SOLD IN 2014 AND THIS IS THE ONLY FAILURE OF THIS COMPONENT REPORTED FOR THAT PRODUCTION YEAR. 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 FRACTURING CAUSING THE LIGHT TO FALL. THERE WERE NO INJURIES.