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); Material Integrity Problem (2978)

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

Event Date 01/01/2015

Event Type  malfunction  

Event Description

Nidek inc.Received a complaint from a customer on (b)(6) 2015.Doctor reported that he had received the nidek inc.Yc-1800 recall notification letter.Doctor also reported that he had noticed pitting lens in 5 of his patients.Doctor mentioned that it was just small pitting and none of the patients had any adverse events and no medical or surgical intervention was required for this issue.

Manufacturer Narrative

The affected device has not been returned to nidek.The inspection has not done yet so the results of evaluation are not available.Nidek customer service manager contacted customer to gather additional information.Doctor confirmed that in total five patients had pitting in the lens over the period of 6 months.Dates of surgery have not been provided.However doctor provided patient information and confirmed that none of the patients hand any kind of adverse events and no medical and surgical treatment was required for pitting.Nidek asked customer to send the device back to nidek for evaluation.The device will be evaluated by the nidek service engineer.Should new information that changes the facts and/or conclusion of this report become available, a supplemental 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.Additional four mdrs will be submitted for additional four patients.

Manufacturer Narrative

The device was returned back to nidek on 9/23/2015.The device was evaluated by nidek service engineer (se) on 10/22/2015.The device was tested and inspected for proper function.The laser energy output was tested and verified.Focus and alignment of yag/ aiming beam was check and verified.No failure was found.The se confirmed that the device operated within specifications.However, as per customer's request the device was exchanged with another yc-1800 sn: (b)(4) by nidek.

• 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 ; 5103537785
• MDR Report Key: 4905206
• MDR Text Key: 22151664
• Report Number: 3002807715-2015-00029
• Device Sequence Number: 1
• Product Code: LXS
• 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 Facility,health professional,oth
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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
• Patient Age: 77 YR