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

Model Number YC-1800

Device Problems Nonstandard Device (1420); Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

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

Event Date 01/01/2015

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to nidek.However the field service engineer will do the inspection at the customer site at later date.The inspection has not done yet so the results of evaluation are not available.Nidek customer service contacted doctor to gather additional information regarding the complaint that time doctor reported that the aiming beam was inconsistent.Doctor did not provide any additional details regarding the pitting lens like number of patients involved or any other patient information.However nidek confirmed that there have been no adverse event to the patients.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 received a complaint from a customer on (b)(6) 2015.Nidek recall team contacted the customer during the follow up for the recall related to the (b)(6) that time doctor reported that he had experienced pitting lens few times in the past.Doctor also mentioned that it might have something to do with the button of the device.Doctor requested to talk to customer service/respected department regarding this at the time.No injury was reported at the time.

Manufacturer Narrative

The device was not returned to nidek.However the device has been evaluated by nidek field service engineer (fse) on site.The device was tested by the fse.Customer complaint about the failure of the button (power knob) was verified.Fse found a failure in the gear mesh between the potentiometer and the ½ lambda plates inside the power knob.As per fse when the power knob was moved in clockwise direction the displayed energy of the self-test matched output energy.However, when the knob was moved in counter clockwise direction the slop in the potentiometer caused the display energy to be on the higher on the first and then next shot it dropped lower and lower until it matched the actual energy.Fse adjusted the gear mesh and the problem has been resolved.The energy output difference due to power knob failure is the most likely cause of pitting in this case.Fse also checked the aiming beam and no problem was found.Fse also advised and explained the doctor to use a systematic approach while using the device which is by using the lower energy and defocusing manually even with the focus set to 150 um to avoid pitting lens.Nidek considers this failure mode as a reportable event as the device has malfunctioned and the recurrence of the focus issue has potential to cause or contribute to an adverse event.

• 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: neo yamaguchi ; 47651 westinghouse drive; fremont, CA 94539-7474 ; 5103537785
• MDR Report Key: 5115074
• MDR Text Key: 27321358
• Report Number: 3002807715-2015-00046
• 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,other,use
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• 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: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2010
• 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