YC-1800

Additional Manufacturer Narrative

ON APRIL 5, 2018, THE DEVICE IN QUESTION WAS EVALUATED AT THE USER'S FACILITY BY A NIDEK INC. FIELD SERVICE ENGINEER (FSE). FSE MEASURED 56V AC FROM GROUND TO HEADREST AND BODY OF LASER. THE AC POWER CORD APPEARS TO HAVE BEEN STEPPED ON THE BASE OF THE ALCON TABLE. FSE REMOVED THE POWER CORD AND FOUND DAMAGE TO THE END. BAD ELECTRICAL GROUNDING ON AC POWER CORD AND FRAME OF TABLE FLOATING AT 56V AC. FSE REPLACED AC POWER CORD WITH FACILITY'S SPARE POWER CORD, AND TESTED VOLTAGE FROM ELECTRICAL GROUND TO LASER BODY TO CHINREST AND FOUND VOLTAGE MEASURED AT BELOW 50MVAC. LEAKAGE VOLTAGE WAS NOW WITHIN SPEC. NIDEK INC. DETERMINED THAT ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE WAS DUE TO DAMAGED AC POWER CORD OF THE ALCON TABLE. THE LASER WAS PLACED ON UNGROUNDED NON-NIDEK PRODUCT (ALCON TABLE) WHICH CAUSED HIGH ELECTRICAL LEAKAGE VOLTAGE. THUS, THE ISSUE WAS NOT CAUSED BY A NIDEK INC PRODUCT. AFTER THE DEVICE EVALUATION, THE LASER IS NOW OPERATIONAL.

Description of Event or Problem

ON (B)(6) 2018, NIDEK INC. RECEIVED A PHONE CALL FROM A CUSTOMER STATING THAT WHILE THE USER'S FACILITY DOCTOR WAS PERFORMING A PROCEDURE ON A PATIENT, AN ELECTROSTATIC SHOCK FELT TO THE RIGHT HAND OF THE DOCTOR AND AT THE SAME TIME, THE PATIENT ALSO FELT THE ELECTROSTATIC TO THE LEFT EYE. THE PROCEDURE WAS PAUSED AND WILL RESUME AFTER THE LASER EVALUATION. AT THIS TIME, NIDEK HAS NO ADDITIONAL INFORMATION OF DOCTOR AND PATIENT CONDITION BUT A SUPPLEMENTAL FOLLOW-UP WILL BE SUBMITTED ONCE BECOME AVAILABLE.

Additional Manufacturer Narrative

ON MAY 15, 2018, NIDEK INC'S MDR SPECIALIST CONTACTED THE CUSTOMER BY PHONE AND IN RESPONSE, IT WAS ACKNOWLEDGED THAT THE CONDITION OF THE FACILITY DOCTOR AND THE PATIENT INVOLVED WERE FINE AND ALSO, NO MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION CAN BE VERIFIED UNDER FOLLOWING SECTIONS IN THIS FORM.

Description of Event or Problem

PLEASE SEE THE INITIAL MDR SUBMITTED ON MAY 2, 2018.