YC-1800
Received Apr 27, 2018 · Event occurred Mar 14, 2018
Report 0002936921-2018-00005 · MDR key 7470961
Device
Generic name
Yag Laser
Manufacturer
Nidek Co., LtdProduct problems
- Unexpected Therapeutic Results
- Device Operates Differently Than Expected
- Unexpected Therapeutic Results
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
ON 4/18/2018, THE DEVICE IN QUESTION WAS EVALUATED AT THE USER'S FACILITY BY A NIDEK INC. FIELD SERVICE ENGINEER (FSE). FSE TURNED ON LASER, CHECKED THE FOCUS SHIFT OFF-SET WITH MICROMETER AND AT ZERO (0) OFF-SET. OFF-SET WAS 50 MICRONS ANTERIOR (WITHIN ACCEPTABLE RANGE OF 0 TO ± 50 MICRONS). ALSO CHECKED ACTUAL ENERGY, AT A DISPLAYED VALUE OF 4.4MJ ON LASER THE FIELD MAX METER READS 4.2MJ (WITHIN ACCEPTABLE RANGE TO PRESET VALUE ± 15 %). FSE ADJUSTED THE FOCUS SHIFT OFF-SET TO ZERO MICRON AND ADJUSTED DISPLAY TO MATCH FIELD MAX READINGS AND RETESTED THE LASER. AS EXPECTED, THE LASER IS OPERATIONAL AT ALL SETTINGS AFTER THE SERVICE WAS COMPLETED. NIDEK INC. DETERMINED THAT MOST PROBABLE CAUSE OF THE PITTING LENS REPORTED WAS DUE TO THE COMBINATION OF FOCUS SHIFT OFF-SET BEING SET LESS THAN INDICATED AND USER NOT PROPERLY ALIGNING THE X/Y AXIS DURING THE PROCEDURES.
Description of Event or Problem
ON (B)(6) 2018, NIDEK INC. RECEIVED A PHONE CALL FROM A CUSTOMER STATING THAT FOR THE PAST THREE (3) WEEKS, THEIR YC-1800 HAS BEEN PITTING LENSES WHILE PERFORMING PROCEDURES ON PATIENTS. THE CUSTOMER CLAIMED BY TURNING THE LASER OFF AND ON, THE PROCEDURES CAN BE EXECUTED WITH NO ISSUES. AT THIS TIME, NIDEK INCORPORATED HAS NO INFORMATION OF HOW MANY PATIENTS WERE INVOLVED. NIDEK MADE SEVERAL EMAILS AND PHONE CALLS ATTEMPTS, HOWEVER NO REPLY OR RESPONSE FROM THE CUSTOMER. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED ONCE PATIENT(S) INFORMATION ARE AVAILABLE. THUS, NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUE TO RECUR.
Additional Manufacturer Narrative
ON (B)(6) 2018, NIDEK INC. RECEIVED AN EMAIL RESPONSE FROM THE CUSTOMER. THE FACILITY DOCTOR CLAIMED THAT THERE WERE NO ADVERSE EVENTS TO REPORT. NO PITTING LENSES HAD OCCURRED AND THAT THE AIMING BEAM SEEMED OUT ALIGNMENT, NOT FOCUSING. ALSO, THE DOCTOR HAS MENTIONED THAT NO ISSUES TO REPORT REGARDING ANY PATIENTS. NIDEK DETERMINED THAT NO FURTHER ACTION REQUIRED BASED ON DOCTOR'S REMARK. PLEASE SEE CUSTOMER'S EMAIL RESPONSE FOR COMPLETE DETAILS.
Description of Event or Problem
PLEASE SEE THE INITIAL MDR SUBMITTED ON APRIL 27, 2018.