YC-1800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-16 for YC-1800 manufactured by Nidek Co. Ltd..

Event Text Entries

[146489758] The customer device yc-1800 #y1620029 was recently repaired by nidek inc. On 4/12/2019. The doctor performed 10 procedures between (b)(6) 2019, but observed 2 incidents of pitting lens. The doctor is currently operating loaner device # y1620097 and has no problem with the device functionality. At this time, evaluation on the yag laser is on-going; a supplemental follow-up report will be submitted once the device evaluation and repair are completed.
Patient Sequence No: 1, Text Type: N, H10


[146489759] Nidek inc. Sales manager received a telephone call from the customer on (b)(6) 2019 to report that their yag laser yc-1800 was malfunctioning. The doctor was noticing pitting lens and was having trouble focusing. Nidek inc. Service manager spoke to the customer on (b)(6) 2019. Based on doctor's remarks, the aiming beam to yag laser beam alignment was off; the yag laser beam focuses 120? M anterior with respect to the aiming beam. The surgeries were complete eventually by setting the yag laser with 250? M focus shift posteriorly at energy 1. 4 mj. There were two cases of pitting lens reported, thereby, two individual reports will be submitted. This report is submitted for a female patient with monofocal type iol on the right eye. However, there was no patient injury reported. Nidek inc. Considers pitting lens issue a reportable event as it is an undesirable condition and has a potential to cause or contribute to a serious injury if the issue were to recur.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936921-2019-00006
MDR Report Key8617969
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-05-16
Date of Report2019-07-18
Date of Event2019-04-19
Date Mfgr Received2019-04-19
Device Manufacturer Date2016-12-09
Date Added to Maude2019-05-16
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 ContactMR. TODD MILHOLLAND
Manufacturer Street2040 CORPORATE COURT
Manufacturer CitySAN JOSE CA 951317474
Manufacturer CountryUS
Manufacturer Postal951317474
Manufacturer Phone5103537702
Manufacturer G1NIDEK CO. LTD.
Manufacturer Street34-14 HIROSHI
Manufacturer CityGAMAGORI, 443-0038
Manufacturer CountryJA
Manufacturer Postal Code443-0038
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameYC-1800
Generic NameYAG LASER
Product CodeLXS
Date Received2019-05-16
Returned To Mfg2019-04-29
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 HIROSHI GAMAGORI, 443-0038 JA 443-0038


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-05-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.