YC-1800
Received Jun 15, 2018 · Event occurred May 23, 2018
Report 0002936921-2018-00008 · MDR key 7607909
Device
Product problems
- Device Operates Differently Than Expected
- Output Problem
- Device Operates Differently Than Expected
- Output Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS EVALUATED BY NIDEK FIELD SERVICE ENGINEER (FSE) ON 06/12/2018 AT THE USER FACILITY. THE CUSTOMER REPORTED ISSUE "DISPLAY ENERGY JUMP UP/DOWN DURING THE PROCEDURE" COULD NOT BE VERIFIED OR DUPLICATED. POWERED ON THE SYSTEM AND FOUND IN WORKING ORDER. THE FOLLOWING ARE THE SERVICE ACTIVITIES PERFORMED: ·PERFORMED PFN (PULSE FORMING NETWORK) VOLTAGE CALIBRATION. ·PERFORMED ENERGY MONITOR CALIBRATION. ·CHECKED AND VERIFIED THE DISPLAYED ENERGY AND ACTUAL ENERGY FOR 0.3/1.0/3.0/5.0/7.5/10.0MJ. ·CHECKED AND VERIFIED THE DISPLAY ENERGY IS NOT JUMPING UP/DOWN DURING PROCEDURE. ·CHECKED AND VERIFIED YAG FOCUS SHIFT. ·CHECKED AND VERIFIED AIMING BEAM ALIGNMENT. ·CHECKED AND VERIFIED MECHANICAL AND OPERATIONAL FUNCTION OF THE UNIT. SYSTEM IS OPERATIONAL. FSE REVISITED THE USER FACILITY THE FOLLOWING DAY, ON (B)(6) 2018 UPON THE CUSTOMER'S REQUEST FOR OBSERVING THE PROCEDURE WITH DOCTOR AND FOUND SATISFACTORY. CUSTOMER REPORTED ISSUE "DISPLAY ENERGY UP/DOWN DURING THE PROCEDURE" IS INCONCLUSIVE. NO INJURIES REPORTED, HOWEVER, NIDEK INC. CONSIDERS THIS FAILURE MODE A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.
Description of Event or Problem
NIDEK INC. RECEIVED A COMPLAINT FROM THE CUSTOMER ON (B)(6) 2018. CUSTOMER REPORTED THAT WHILE PERFORMING PROCEDURES WITH THE YC-1800 SN: (B)(4), DOCTOR NOTICED THAT THE POWER ON LASER WAS INCREASING. DOCTOR HAD TO MANUALLY LOWER THE ENERGY ON THE UNIT. NO INJURY WAS REPORTED AT THAT TIME.