MAUDE Adverse Event Report: NIDEK INC. EC-5000 CXIII; EXCIMER LASER

Device Problems Leak/Splash (1354); Fumes or Vapors (2529); Gas/Air Leak (2946)

Patient Problems Dry Eye(s) (1814); Dyspnea (1816); Headache (1880); Burning Sensation (2146); Sore Throat (2396)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

· nidek field service engineer (fse) evaluated device at customer's site on 4.13.2017 and verified gas leak at base of halogen.Filter in gas cabinet.Fse found bad check/leak valve.· fse replaced bad check/leak valve with known good part.Tested device, leak tests passed.As a precautionary measure, the nitrogen tank was replaced and re-installed premix tank, passed leak test.· fse performed routine ablation rate calibration.Normal 168mj (25.1kv) attenuators out / flex scan 156mj (24.5kv) attenuators out.Hyperopia +3.00d @ 48 sec.Linear scan offset.Tested and inspected, excimer operational.· the ec-5000 operator manual states: in the event of gas leakage, a sensor detects the f2 gas (detectable concentration of 1 ppm) and an audible system alarm is triggered.When this occurs, the f2 (premix) gas supply line must be manually closed as a gas warning appears on the display monitor.· the alarm did not trigger during gas leak because fse believed this was due to the gas being less concentrated and the leak occurred through the leak/check valve which is directly connected to a halogen filter, thus being diluted before it entered the room atmosphere.· based on fse assessment, the leak/check valve failed because it was likely due to the customer not following proper protocol while changing the premix tank.· however, the site technician claimed that she was brieftly trained by a service tech but not a nidek's employee to change the premix gas and had changed the gas a couple of months ago with no issue.· based on service installation record, the excimer laser was first sold on (b)(6) 2007 by different company and was later bought by this current user facility.The customer has owned this excimer laser since (b)(6) 2011, and has had 18 service calls and this was the first replacement on the check/leak valve component.· in conclusion, nidek incorporated determined that the probable cause of the excimer laser gas leakage issue was due to a defective check/leak valve component.Overtime usage most likely caused the check/leak valve to malfunction as the excimer laser has been operating for more than 10 years.This is a first-time occurrence of this issue.Thus, the device functions properly and no gas leak detected after the check/leak valve component was replaced.· the two female employees of (b)(4) experienced burn (dry) sensation on their eyes and both did not feel well that day.· based on customer's email, one employee in questions had a headache and burning eyes, and the second employee had trouble breathing and a sore throat but both did not see a medical doctor and are feeling well after the incident.· the excimer laser operator's manual states: as a safety device against the leakage of fluorine (f2) gas from the main body, the inside of the system is always ventilated.When the laser gas is exhausted from the main body, the built-in halogen filter decreases the concentration of the gas to a safe level.Please see attached mdr cover letter and customer emails for references.

Event Description

On (b)(6) 2017, nidek inc.Customer service received a telephone call from a customer to report that they detected a premix gas leakage while they were changing the premix tank by following guidelines on the device's screen on their ec-5000cxiii serial #(b)(4).One of the technicians noticed after turning off the gas bottle after the fill, the gauge only read 10 mpa, which is supposed to be at 20 mpa.The following week they had turned the laser on and tried to do a new fill again, that's when the leak was really noticed.Although, there was no patient during the discovery, two facility employees didn't feel well and felt burning (dry) sensation with their eyes that day.Please note that two mdr medwatch forms will be submitted, one for each employee involved in this adverse event issue.

• Brand Name: EC-5000 CXIII
• Type of Device: EXCIMER LASER
• Manufacturer (Section D): NIDEK INC.; 47651 westinghouse drive; fremont CA 94539 7474
• Manufacturer (Section G): NIDEK CO. LTD; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• Manufacturer Contact: preeti bhatia ; 47651 westinghouse drive; fremont, CA 94539-7474 ; 5103537718
• MDR Report Key: 6544672
• MDR Text Key: 74432654
• Report Number: 0002936921-2017-00003
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR