MAUDE Adverse Event Report: NIDEK NIDEK YC 1800 OPHTHALMIC LASER

Device Problems Use of Device Problem (1670); Computer Operating System Problem (2898); Manufacturing, Packaging or Shipping Problem (2975); No Fail-Safe Mechanism (2990)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Nidek yc-1800 ophthalmic laser.Potentially dangerous design flaw.This is a combination ophthalmic laser.When powered on in the photocoagulation (ie.Non-yag mode, the previous users' settings are restored, including photocoagulation power and duration.If the previous treatment required high power (eg.Laser iridotomy) then the machine will next power up with the same high power setting.If this is not noticed by the operator, then a dangerously high power may be inadvertently applied to the next pt.It would be preferable for the device to power up with all settings at minimal levels.

• Brand Name: NIDEK YC 1800 OPHTHALMIC LASER
• Type of Device: OPHTHALMIC LASER
• Manufacturer (Section D): NIDEK
• MDR Report Key: 5781798
• MDR Text Key: 49295324
• Report Number: MW5063321
• Device Sequence Number: 1
• Product Code: HQF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1