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

Model Number YC-1800

Device Problems Energy Output To Patient Tissue Incorrect (1209); Misfocusing (1401)

Patient Problem No Code Available (3191)

Event Date 01/01/2013

Event Type  malfunction  

Event Description

Nidek, inc.Received a complaint ((b)(4)) from a customer.The user facility reported that while using yc-1800; (b)(4) a clear image was observed from slit lamp but the image form side scope was not clear.Customer also mentioned that the focus shift was off causing the pitting lenses.The procedure was completed with no patient injury.

Manufacturer Narrative

The affected device was not returned to nidek for evaluation.However, a nidek field service engineer (fse) had conducted an on site evaluation and determined that the treatment output energies were higher than the display screen and had subsequently readjusted to meet specifications.Fse also found the focus shift point was off and adjusted the focus shift.The system has been working appropriately to date.Nidek have not received any complaints or injury related to the device to date.On (b)(4) 2014, nidek clinical specialist made attempts to contact the assigned fse via phone and e-mail to gather additional information regarding the reported event without success.If additional significant information is received at a later date, a follow-up report will be submitted.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.

• 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- 0038; JA 443-0038
• Manufacturer Contact: neo yamaguchi ; 47651 westinghouse dr.; fremont, CA 94539 ; 5105572550
• MDR Report Key: 4080821
• MDR Text Key: 4744239
• Report Number: 3002807715-2014-00006
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K893987S
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: Yes
• 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?: No
• Date Manufacturer Received: 07/12/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• 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