YC-1800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,oth report with the FDA on 2015-07-07 for YC-1800 manufactured by Nidek Co., Ltd..

Event Text Entries

[15959542] 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.
Patient Sequence No: 1, Text Type: D, B5


[16299478] The affected device has not been returned to nidek. The inspection has not done yet so the results of evaluation are not available. Nidek (b)(4) 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 had 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 (b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10


[33000101] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002807715-2015-00030
MDR Report Key4905207
Report Source05,06,HEALTH PROFESSIONAL,OTH
Date Received2015-07-07
Date of Report2015-10-22
Date of Event2015-01-01
Date Mfgr Received2015-10-22
Device Manufacturer Date2014-08-01
Date Added to Maude2015-07-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNEO YAMAGUCHI
Manufacturer Street47651 WESTINGHOUSE DRIVE
Manufacturer CityFREMONT CA 94539
Manufacturer CountryUS
Manufacturer Postal94539
Manufacturer Phone5103537785
Manufacturer G1NIDEK CO., LTD.
Manufacturer Street34-14, HIROISHI, GAMAGORI,
Manufacturer CityAICHI 443-0038
Manufacturer CountryJA
Manufacturer Postal Code443-0038
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number2936921-2/20/2015-001-C
Event Type3
Type of Report3

Device Details

Brand NameYC-1800
Generic NameND: YAG LASER
Product CodeLXS
Date Received2015-07-07
Returned To Mfg2015-09-23
Model NumberYC-1800
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNIDEK CO., LTD.
Manufacturer Address34-14, HIROISHI, GAMAGORI, AICHI 443-0038 JA 443-0038


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-07

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