MAUDE Adverse Event Report: GYC-1000; GREEN LASER PHOTOCOAGULATOR SYSTEM

Model Number GYC-1000

Device Problems Unexpected Therapeutic Results (1631); Patient-Device Incompatibility (2682); Firing Problem (4011)

Patient Problem Red Eye(s) (2038)

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

Nidek inc.Considers this issue on gyc-1000 as a reportable event as an undesirable condition occurred while using the device.Nidek inc.Is awaiting device evaluation and additional information from the customer facility with respect to the malfunctioning of the laser, along with updates to patient's condition after observing the "bloodshot red" eye.A supplemental follow-up report will be submitted when the information becomes available.

Event Description

On 8/30/2021, nidek inc.Customer service received a phone call from a customer (ophthalmic technician) to report that doctor feels the gyc-1000 laser s/n (b)(4) is firing "hot".The doctor was using the laser on friday, (b)(6) 2021 and reports that after the first shot she noticed the patient's eye was "bloodshot red".Doctor also noticed error 53 (malfunction of the trigger switch detection circuit) on the laser display after the incident.The complaint occurred while using the gyc-1000 in the customer facility's laser room.According to the customer, the "patient seemed to be ok but they will have to confirm at their follow-up appointment in 3 weeks".Nidek inc.Considers this issue on gyc-1000 as a reportable event as an undesirable condition occurred while using the device.Technical background: the green laser photocoagulator system gyc-1000 is an ophthalmological photocoagulation system using a solid state laser (green laser beam) with a wavelength of 532nm.Like conventional laser photocoagulation systems, this system is used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.The gyc-1000 can be used with various kinds of delivery units, such as slit lamp or binocular indirect ophthalmoscope.

Event Description

Please see initial mdr submitted on 01-sep-2021.

Manufacturer Narrative

Nidek inc.Determined that the cause of the customer complaint's issue "error 53: malfunction of the trigger switch detection circuit' was due to a defective foot switch, potentially from wear and tear and/ or faulty connection cable.Error 53 occurs when there is no laser emission while pressing the foot switch, therefore, "laser firing 'hot' " is not a result from the error 53.Hence, cause with which doctor has felt that the 'laser was firing hot' is inconclusive.Patient follow-up response was received from the customer on 10/1/2021: "the patient that the dr.Feels the laser was firing hot is doing just fine.We have seen her multiple times since this occurred and her eye is fine." during the initial servicing at customer's facility on 9/3/2021 by nidek inc.Field service manager (fsm), the error 53 could not be duplicated.Inspection was completed for both gyc-1000 s/n (b)(6) and gyc4sg-2(haag attachable slit lamp delivery unit ) s/n (b)(6) and were found to be in working order.The haag delivery's protective filters were intact and positioned properly.Fsm proceeded cleaning the haag delivery optics and slit-lamp oculars.To prevent intermittent error 53, fsm cleaned and adjusted the foot-switch dual micro-switches.After calibrating the haag delivery's power output and display parameters, the system was tested and inspected and verified as operational.After the servicing completed on 9/3/2021, error 53 was once again reported on the same gyc-1000 device s/n (b)(6).Customer service has sent a replacement foot switch on 9/24/2021, and service call has been closed on 10/29/2021 as the customer has been using the footswitch for 30 days and has not had another occurrence of error 53.

• Brand Name: GYC-1000
• Type of Device: GREEN LASER PHOTOCOAGULATOR SYSTEM
• MDR Report Key: 12411601
• MDR Text Key: 280606455
• Report Number: 0002936921-2021-00003
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• PMA/PMN Number: K032085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GYC-1000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• 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