MAUDE Adverse Event Report: NIDEK CO., LTD. GYC-1000; GREEN LASER PHOTOCOAGULATOR SYSTEM,

Model Number GYC-1000

Device Problem Output above Specifications (1432)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

Nidek inc., received a complaint from a customer on (b)(6) 2015.Customer reported that during the use of gyc-1000, sn (b)(4).Dr.(b)(6) is complaining that the output power appeared to be higher than what it is set at.Doctor mentioned that the reduced the power and duration to complete the procedure.No pt injury was reported at that time.

Manufacturer Narrative

The affected device was not returned to nidek for eval.However, a nidek fse had conducted an on site eval.The device was evaluated and tested for proper operation.Actual energy and display energies were measured and fse found that the actual energy was higher than the display energy.The device was calibrated and the actual energy was measured again.After the adjustment fse confirmed that the readings were within specs.Nidek contacted the doctor for f/u and found that the issue has not been resolved.Doctor reported that the laser was still hot and had to turn the power way down to complete the treatment.On further discussion doctor mentioned that he observed an exaggerated reaction with laser at the settings which he uses regularly.Doctor had to lower the power to get the desired reaction.Doctor confirmed that the pt did not get any injury and he could complete the pt treatment at low power with success.No pt has been affected so no pt info was provided by the doctor.

Manufacturer Narrative

(b)(6) 2015 nidek clinical specialist contacted field service engineer (fse) to gather additional information regarding the onsite evaluation performed by the fse on 5/20/2015.Fse confirmed that he checked the power output and the output was at higher side.However, the power output was within the specifications as per the measurement range.Fse did not find any failure in the device.Fse also mentioned that he had advised the customer to send the device to nidek for further evaluation.On 8/26/2015 the device was returned back to nidek.On 9/18/2015 the device was tested and evaluated by nidek service engineer (se) on 9/18/2015.The complaint was regarding the high power output.Se checked the power output and confirmed that the power output was within the specifications.The device was calibrated and se adjusted the power to minimum level according the power output measurement range.Internal and external optics were checked and cleaned as per the specifications.The device has been tested for proper functions.The device was returned back to the customer.Clinical specialist confirmed that the device was purchased by the customer in (b)(6) 2014.Historical review was performed for gyc-1000 sn: (b)(4).The inspection record shows that the device had passed the inspection at that time.This is the first occurrence of the issue.On (b)(6) 2015 nidek clinical specialist contacted the customer (technician) for follow and confirmed that the device has been functioning properly.

Manufacturer Narrative

Nidek inc.Is submitting a follow up medwatch form as a correction to the initial medwatch submitted by nidek inc.On 10/15/2015.( mfr #:3002807715-2015-00025.) nidek has inadvertently provided the incorrect information in mfr #:3002807715-2015-00025.The incorrect information is brand name: yc-1800, common device name: nd: yag, model: yc-1800, 510k #: k893987.Nidek inc.Would like to provide the correct information as brand name: gyc-1000, common device name: green laser photocoagulator system, model: gyc-1000, 510k #: k032085.

• Brand Name: GYC-1000
• Type of Device: GREEN LASER PHOTOCOAGULATOR SYSTEM,
• Manufacturer (Section D): NIDEK CO., LTD. ; 34-14, hiroshima; 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 dr.; fremont, CA 94539 ; 5103537785
• MDR Report Key: 4859216
• MDR Text Key: 5850505
• Report Number: 3002807715-2015-00025
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GYC-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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