OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR NM-400U-0525

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR NM-400U-0525 manufactured by Olympus Medical Systems Corp..

Event Text Entries

[144942708] Equipment malfunction. Needle would not prime and medication could not be injected.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086545
MDR Report Key8600507
Date Received2019-05-09
Date of Report2019-04-29
Date of Event2019-04-25
Date Added to Maude2019-05-10
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameOLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR
Generic NameENDOSCOPIC INJECTION, NEEDLE
Product CodeFBK
Date Received2019-05-09
Model NumberNM-400U-0525
Lot Number8ZK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-09

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