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

Model Number GYC-1000

Device Problems Component or Accessory Incompatibility (2897); Device Operates Differently Than Expected (2913); Protective Measures Problem (3015)

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

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

Nidek field service engineer (fse) went to the field for device evaluation on 02/23/2016.The device was evaluated by the fse.Customer complaint for green flashback could not be duplicated.Fse asked to the doctor who saw the flashback, that if the laser was set up properly and that doctor replied yes.The customer unit gyc-1000, (b)(4) will be returned back to nidek for further evaluation.If additional significant information is available at a later date after the evaluation, a follow-up report will be submitted.At this time there was no injury/ adverse event occurred so no patient information is available.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.

Event Description

Nidek inc.Received a complaint from customer on (b)(6) 2016.Customer reported that during the use of gyc-1000 sn: (b)(4), doctor was getting green flashback through slit lamp.There was no flashback when doctor used the indirect ophthalmoscope.No injury was reported that time.

Manufacturer Narrative

The device was returned to nidek for additional evaluation.Nidek in house service engineer (se) evaluated the device on 04/21/2016.No device failure was observed by in-house service engineer.As per field service engineer(fse) who checked the device on site, stated that one possible reason for this complaint is that the operator may have left the bio terminator plug in the gyc1000 after changing the fiber optic that was plugged in the console for the bio to the fiber for the combo delivery.The laser would operate in bio mode, so the protective filter would not close and no error indicated even though the laser beam is being delivered through the combo delivery and exposing the operator looking through the oculars.However, the cause could not be confirmed.The issue had been discussed with the on duty doctor that time.Fse also confirmed that the laser was set up properly at the facility.Additional investigations were performed by nidek (b)(4) on 5/23/2016 to find out the root cause.Dhr was investigated at nidek (b)(4) (nco), and confirmed that the all requirement for nidek quality standard has passed at nidek inspection in (b)(4).Nidek (b)(4) implemented investigation for similar symptoms from the past due to the product is not sent in nidek (b)(4).As per the investigation, in general, people feel "brighter" in case of; the laser wavelength is closer to a peak of luminous sensitivity (about 550nm).The selected laser power is 1w which is considered as high power.Therefore, from those reasons, we consider that the doctor felt brighter.However, the reflection light is sufficiently below mpe value based on the standard ((b)(4)), therefore, it is concluded that there is no adverse effects on doctor's eyes.

• Brand Name: GYC-1000
• Type of Device: GREEN LASER PHOTOCOAGULATOR SYSTEM,
• 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: 5488122
• MDR Text Key: 39935450
• Report Number: 3002807715-2016-00013
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• 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: 03/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2008
• 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