MAUDE Adverse Event Report: NIDEK INC. GYC-500D; GREEN LASER PHOTOCOAGULATOR SYSTEM

Model Number	GYC-500D
Medical Device Problem Codes	Component or Accessory Incompatibility (2897); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Flashers (1864); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Nidek field service engineer (fse) went to the field for device evaluation on (b)(6) 2018.The device was tested and evaluated by the fse.Customer complaint for intense flashback during laser firing on the device gyc-500d serial number: (b)(4) could not be duplicated.Fse powered on the system and found in working order.Tested energies at 100 mw, 200 mw and 500 mw and all are proper.Fse removed the oculars and tested 532 nm filter for any flashback but could still not duplicate any flash back.Checked 532 nm filter for any cracks or scratches and found everything was proper.Tested function of filter all proper.Reseated microscope oculars and test fire on orange paper for proper alignment and spot size.No problem found during device evaluation as the flashback and low energies were inconclusive.Thereby, nidek inc.Determined that the customer's complaint issue was inconclusive.The use of universal mirror lens ( volk hr wide field) could have caused flash/reflection that could have been interpreted as flashback by the doctor.If additional significant information is available at a later date, a follow-up report will be submitted.Nidek inc.Considers flashback issue 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 or Problem Description
Nidek inc.Received a complaint from our territory sales manager on (b)(6) 2018 that the customer (retina specialist) was experiencing intense flashback during laser firing.The doctor was performing prp (panretinal photocoagulation) on a patient using gyc-500d via sl 1800 and a new laser lens.The doctor reported of being unable to effectively treat the patient in spite of a clear view/focus using 200nm spot size / power 1200mw at.10 sec exposure every.20 seconds holding pedal down.The episode of flashing lasted throught the duration of the laser pulse.No injury was reported that time and hence no patient information is available.

• Brand Name: GYC-500D
• Common Device Name: GREEN LASER PHOTOCOAGULATOR SYSTEM
• Manufacturer (Section D): NIDEK INC.; 47651 westinghouse drive; fremont CA 94539 7474
• MDR Report Key: 7558683
• Report Number: 0002936921-2018-00007
• Device Sequence Number: 1262145
• Product Code: HQF
• UDI-Device Identifier: 04987669100851
• UDI-Public: (01)04987669100851
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K152603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GYC-500D
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1