MI-1000

Additional Manufacturer Narrative

MEDICAL ILLUMINATION EXAMINED THE SUPPLIED PHOTOGRAPHS AND IT WAS APPARENT THAT THE LIGHT WAS NOT INSTALLED PER THE INSTRUCTIONS. WHEN PROPERLY INSTALLED, THE PIN IS INSERTED THROUGH A HOLE IN THE CEILING ROD AND THIS PIN SITS IN A RECESS IN THE MOUNTING CASTING. THE PIN, WHICH SUPPORTS THE WEIGHT OF THE LIGHT FIXTURE IS PREVENTED FROM MOVING BY THE WALLS OF THE RECESS. THE PHOTOS SHOWED THAT THE ROD WAS INSTALLED TOO HIGH IN THE CEILING CASTING WITH ONLY THE SET-SCREW HOLDING THE ROD IN PLACE AND THE PIN NOT PROPERLY SEATED. THIS WAS EVIDENT IN THAT THE SCARRING ON THE PAINTED SURFACE INDICATED THAT THE ROD WAS NOT PROPERLY SEATED IN THE CASTING WHICH ALLOWED THE ROD TO "WOBBLE" GIVING A PATHWAY FOR THE PIN TO WORK ITS WAY OUT OF THE ROD. THE INSTALLATION OF THE LIGHT WAS DEEMED TO BE IN ERROR AND IT WAS COMMUNICATED TO DR. (B)(6) VIA EMAIL ON (B)(6) 2015. FURTHER INVESTIGATION ALSO INDICATED THAT THE INITIAL REPORT THAT THE LIGHT HIT THE SCRUB NURSE AND PATIENT WAS ERRONEOUS BY THE DOCTOR WHO PERFORMED THE PROCEDURE THAT THE LIGHT DID NOT HIT THE DOCTOR, STAFF OR PATIENT. THE FINAL COMMUNICATION IN THIS CASE WAS THE DOCTOR WANTED THE LIGHT REINSTALLED AS SOON AS POSSIBLE. THIS CASE WAS CLOSED ON (B)(4) 2015.

Description of Event or Problem

ON (B)(6) 2015 AN INCIDENT WAS REPORTED TO MEDICAL ILLUMINATION REGARDING AN MI-1000 LIGHT FALLING DURING A PROCEDURE ON (B)(6) 2015. THE INITIAL REPORT STATED THAT THE DOWEL PIN BROKE AND THE LIGHT FELL AND HIT THE DOCTOR, THE SCRUB NURSE AND THE PATIENT BUT NO OTHER DETAILS WERE GIVEN. PICTURES WERE ALSO SUPPLIED OF THE SUSPECTED FAILED COMPONENT, THE MOUNTING ROD DOWEL PIN.