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 11/09/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the nidek.However, the device was evaluated by the nidek field service engineer fse at the facility on 12/15/2015.Fse tested and evaluated the device.Complete operational check was performed and device passed the tests performed.Fse also checked the laser beam profile using the polarized film at 24kv, 30kv and 1hz and found weak center within profile.Fse advised to replace the front and the rare optics to correct reported problem.After interview with the technician fse found out that the customer is using third party to perform the preventive maintenance service on the device.Last preventive maintenance was performed in early (b)(6) 2015 by the third party.Fse recommended customer that the laser should be maintained by the qualified nidek inc.Service personnel.(reference: as per the operator's manual for ec-5000; 3: safety; 3.7: maintenance and check: only nidek service personnel should disassemble and repair the system.) nidek clinical specialist contacted technician to gather additional patient information on 12/22/2015.In total three patients had undercorrection and all the patients were in healing phase.Nidek inc.Considers it 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.Separate mdr will be submitted for all three patients.Please refer the table below for additional details.Age: 44yrs, sex: male, date of surgery performed: (b)(6) 2015, mdr #: 3002807715-2016-00001.Age: 47 yrs, sex: male, date of surgery performed: (b)(6) 2015, mdr #: 3002807715-2016-00002.Age: 20 yrs, sex: female, date of surgery performed: (b)(6) 2015, mdr #: 3002807715-2016-00003.

Event Description

Nidek received a complaint on (b)(6) 2015 from customer.Customer reported that during the use of ec-5000 sn: (b)(4).Doctor observed undercorrection on the three patients.Additional details were not provided at that time.

Manufacturer Narrative

This report is to provide the update in regards to the complaint for undercorrection for the ec-5000.Nidek field service engineer (fse) contacted customer on (b)(4) 2016 for follow up.During the evaluation of the device on (b)(6) 2015 at the field nidek fse recommended customer to replace the front and the rare optics to correct reported problem.On (b)(4) 2016 customer reported that they have used the third party to do the replacement of the parts and the device has been working fine.The issue of undercorrection has been resolved.

• 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: neo yamaguchi ; 47651 westinghouse drive; fremont, CA 94539-7474 ; 5103537785
• MDR Report Key: 5352816
• MDR Text Key: 35316145
• Report Number: 3002807715-2016-00003
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• 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: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2004
• 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 Age: 20 YR