MAUDE Adverse Event Report: NIDEK CO., LTD. YC-1800; ND:YAG LASER

Model Number YC-1800

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

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

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

Nidek field service engineer (fse) evaluated the device on 02/26/2016 in the field.Hence the device was not returned to nidek.Fse tasted and evaluated the device.Measured and recorded initial energy values and found calibration off.At 4.2mj actual output was 3.14mj.Removed energy control and found 1/2 lambda plate burned.Fse cleaned 1/2 lambda plate with methanol and observed that damage was all on bottom side (beam exit side) of optic.Reinstalled energy control assembly and calibrated laser.Final measurements were recorded and were within the specifications.Calibration was possible after the lambda plate was cleaned indicating no issue.Fse tested the laser for proper operation and found laser was ready to be used.A pm label was attached to the yag with the next calibration due date, and this issue was discussed with doctor and the technician.Additionally fse verified complaint with technician and confirmed the one patient, a male, was treated with the yag and doctor complained that the laser had pitted the lens of this patient 8 times.This was the only patient affected.No additional treatment was necessary for the patient.The date of surgery was (b)(6) 2016.The settings used were 4.0-4.5mj, "0" focus shift and (b)(4) lens was not used.They are not sure when the laser was serviced last, and are not sure if recall letter was received.As per fse due to lack of regular maintenance this laser was way out of calibration.The display energy (energy which the doctor expected to be delivered) did not match the actual output.As per fse even though the laser was out of calibration doctor kept on using the laser.The calibration issue could be the cause for the pitting of the lens in this case.Clinical specialist reviewed service record for this device.The device was manufactured in 2009.No record of preventive maintenance performed in the past is available.Additionally recall record was reviewed to check if the customer had received the letter in the past.As per the record for the yc-1800 recall, notification letter was sent to the customer and response card was received on 6/3/2015.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.Technician reported that during the surgery with yc-1800 sn: (b)(4), doctor observed pitting lens.No additional information was provided that time.On follow up, nidek field service confirmed that only one patient was affected and there were 8 pits in the lens.However, no additional treatment was necessary for the patient.

• Brand Name: YC-1800
• Type of Device: ND:YAG LASER
• 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: 5517540
• MDR Text Key: 40937129
• Report Number: 3002807715-2016-00014
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K893987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: YC-1800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2936921-2/20/2015-001-C
• Patient Sequence Number: 1