SINGLE USE INJECTOR NM-400U-0523

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-11 for SINGLE USE INJECTOR NM-400U-0523 manufactured by Olympus Medical Systems Corp..

Event Text Entries

[80052242] The subject device referenced in this report has not yet been returned to olympus for evaluation. Therefore the exact cause of the reported event could not be conclusively determined at this time. If additional information or the subject device is received at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10


[80052243] During a procedure regarding the gastroenterology, the ten nm-400u-0523's were used. It was reported that the needles could be extracted a little bit, but the needles could not be retracted into the sheath for all ten devices. The procedure was canceled. There was no patient injury reported. This report describes the third device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2017-00857
MDR Report Key6700066
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-07-11
Date of Report2017-08-25
Date of Event2017-06-19
Date Mfgr Received2017-07-31
Device Manufacturer Date2016-11-16
Date Added to Maude2017-07-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR KATSUAKI MORITA
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO-TO
Manufacturer CountryUS
Manufacturer Phone426425177
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSINGLE USE INJECTOR
Generic NameINJECTOR AND SHEATHSET
Product CodeFBK
Date Received2017-07-11
Returned To Mfg2017-07-28
Model NumberNM-400U-0523
Lot NumberK6Y16
ID Number04953170382291
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-11

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