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 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

Nidek field service engineer (fse) went to the field for device evaluation on (b)(4) 2016.The device was tested and evaluated by the fse.Customer complaint for green flashback could not be duplicated.Fse also checked the protective filter and could not find any failure.Fse checked the illumination for the slit lamp and no failure was found.After the service was performed customer called back again to inform that they were getting error 2 and also the slit lamp illumination was uncontrollable.Fse replaced the device with new gyc-1000 (sn: (b)(4)).The customer unit gyc-1000 sn: (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 a customer on (b)(6) 2016.During surgery with gyc-1000, serial number (sn): (b)(4), doctor was getting a green flashback whenever the laser was fired.Doctor also reported that he was wearing protective goggles as a safety.Doctor also complained that the illumination rheostat could not be adjusted and the illumination was at the highest settings.No injury was reported at this time.

Manufacturer Narrative

Device was returned back to nidek for in-house repair.Nidek in-house service engineer (se) evaluated the device on 02/17/2016.Se tested and evaluated the device.Laser output was verified.No failure was found.Nidek (b)(4) had performed additional investigations on 5/23/2016.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 (iec60825-1), 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: 5411557
• MDR Text Key: 37529679
• Report Number: 3002807715-2016-00007
• 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: Physician
• 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: 02/04/2016
• 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: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2010
• 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