MAUDE Adverse Event Report: NIDEK CO., LTD. EC-5000; EXCIMER LASER

Model Number EC-5000

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by nidek field service engineer (fse) on 2/10/2016 in the field, hence device was not returned to nidek.Fse tested and evaluated the device for proper operation.During calibration of the device fse found -3.0 calibrations on test plate was clear, but was unstable due to room environment.Fse found the room temperature at 82-87 degrees and humidity at 19-22 %.Fse observed that the air-conditioner was not working.Fse informed to office manager that he will finish the laser testing on the next day when the ac is working in condition.On the next day ac was working and the room temperature was at 72 degree and humidity was at 22%.Fse calibrated laser numerous times and laser cleared -3.0 d ablation on the test plate.Calibration was stable.(-3.0 calibration is first test on plastic ablation plates to reach a -3.0 diopters on lensometer reading.) fse explained to the manger to keep the room environment stable because if room gets too hot it could cause over-corrections.Temperature should be maintained between 15 - 25ºc (59 - 77ºf) and humidity between 0 - 70%.Reference: operators manual; 3.3.1 before use; caution: "if the above environmental conditions are not satisfied, sufficient laser power output is not obtained." additionally fse tested laser alignment on (b)(4) film and found it within specifications.Office manager mentioned that it was also running out of nitrogen gas.Fse found numerous warning 17 massages (nitrogen error).As per fse even low nitrogen would also be the cause for laser to become unstable.New fill was performed with the new pre-mix gas.The issue has been resolved and system has been operational.Nidek 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.Nidek made attempts to contact the customer to gather additional information regarding the reported event without success.If additional significant information is received at a later date, a follow-up report will be submitted.However, customer reported that two patients had been overcorrected that time.Separate mdr will be submitted for two separate events.Please mdr# 3002807715-2016-00010 and mdr# 3002807715-2016-00011.

Event Description

Nidek inc.Received a complaint on (b)(6) 2016.Customer reported that during surgery on (b)(6) 2016 with ec-5000, sn: (b)(4), doctor observed that two patients were overcorrected.No additional information was provided at the time.

• Brand Name: EC-5000
• Type of Device: EXCIMER LASER
• Manufacturer (Section D): NIDEK CO., LTD.; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• Manufacturer (Section G): NIDEK CO., LTD.; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• Manufacturer Contact: preeti gandhi ; 47651 westinghouse drive; fremont, CA 94539-7474 ; 5103537785
• MDR Report Key: 5485084
• MDR Text Key: 39842031
• Report Number: 3002807715-2016-00011
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC-5000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2000
• 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