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

Model Number YC-1800

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 08/04/2018

Event Type  Injury  

Manufacturer Narrative

We, nidek, checked the joystick (13706-3200) of the device, and found the button of the trigger switch did not go in and out smoothly, and sometimes, it may not return to its original position.We also confirmed that the laser was able to be fired when the trigger switch was pushed from the position where the trigger switch stuck.Disassembling the joystick, and found hand switch (13706 - ea 02) to be hard to push.Therefore, it was determined that the failure of hand switch was the cause of this event.In addition, we did not find any problem with the device other than hand switch.There are no similar complaints in the past six months, therefore; no trends are found.Since it was confirmed that the laser was not fired continuously even if the trigger switch was kept pressed, it is determined that the device was functioning in accordance with its specification.Although this event occurred in a facility in (b)(6), this device is marketed in united state.Nidek determined that it is a reportable event as we became aware of that may have caused or contributed to a serious injury.

Event Description

A doctor reported that after firing the laser, the button of the trigger switch of the joystick with nidek yag laser (model: yc - 1800) got stuck, and laser was fired again.Since the laser was fired at the end of 1st shot, it was defocused, and a pit occurred on the intraocular lens.

• Brand Name: YC-1800
• Type of Device: YAG LASER
• Manufacturer (Section D): NIDEK CO., LTD.; 34-14 maehama, hiroishi-cho; gamagori, aichi 44300 38; JA 4430038
• Manufacturer Contact: noriyuki yamaguchi ; 34-14 maehama, hiroishi-cho; gamagori, aichi 44300-38 ; JA 4430038
• MDR Report Key: 7831804
• MDR Text Key: 118742080
• Report Number: 8030392-2018-00007
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: YC-1800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2011
• 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
• Patient Outcome(s): Required Intervention