RT-5100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-01 for RT-5100 manufactured by Nidek Co., Ltd..

Event Text Entries

[5055881] Nidek received a complaint from the customer on (b)(6) 2014. Customer reported that during the use of rt-5100 sn (b)(4), the near point chart arm fell down. The near point chart arm hit the doctor on the head. Doctor complained of bloody head due to the arm.
Patient Sequence No: 1, Text Type: D, B5


[12711236] The affected device was not returned to nidek for evaluation. The device has not been evaluated yet. Service engineer could conduct an on-site evaluation. Customer reported that the event occurred long time back (date not specified by customer) before the pm was done. Customer then performed the preventative maintenance (pm) according to the recall procedure. The problem has been resolved after the pm. Nidek contacted the customer to verify the complaint about the injury and confirmed that the injury was minor, it was a small dent/laceration. No medical or surgical intervention was required for the injury. Nidek also confirmed that the event had occurred before the pm and the issue has been resolved after the pm. If additional significant information is received at a later date after the evaluation, a follow-up report will be submitted. Nidek inc. Considers it a reportable event as the device has malfunctioned and has a potential cause or contributed to a serious injury if the malfunction were to recur. The facility has two units sn (b)(4) and sn (b)(4) and the complaint could not be confirmed with which device the event happened. So nidek will submit two separate mdr for both the sn. Please refer to mdr 3002807715-2014-00041.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3002807715-2014-00040
MDR Report Key4304379
Report Source05,06
Date Received2014-12-01
Date of Report2014-11-11
Date Mfgr Received2014-11-11
Device Manufacturer Date2009-02-01
Date Added to Maude2014-12-09
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 FDA0
Event Location0
Manufacturer ContactNEO YAMAGUCHI
Manufacturer Street47651 WESTINGHOUSE DR.
Manufacturer CityFREEMONT CA 94539
Manufacturer CountryUS
Manufacturer Postal94539
Manufacturer Phone5103537785
Manufacturer G1NIDEK CO., LTD.
Manufacturer Street34-14 HIROSHI
Manufacturer CityGAMAGORI, AICHI 443-0038
Manufacturer CountryJA
Manufacturer Postal Code443-0038
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRT-5100
Generic NameREFRACTOR
Product CodeHKN
Date Received2014-12-01
Model NumberRT-5100
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNIDEK CO., LTD.
Manufacturer Address34-14, HIROSHI GAMAGORI, AICHI 443-0038 JA 443-0038


Patients

Patient NumberTreatmentOutcomeDate
10 2014-12-01

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