OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR NM-4000-0425

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for OLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR NM-4000-0425 manufactured by Olympus Corporation Of Americas.

Event Text Entries

[141574263] Staff unable to prime injector needle with nss. Product was not used on the pt. No harm to the pt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085689
MDR Report Key8496936
Date Received2019-04-08
Date of Report2019-03-25
Date of Event2019-03-20
Date Added to Maude2019-04-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameOLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR
Generic NameENDOSCOPC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
Product CodeFBK
Date Received2019-04-08
Model NumberNM-4000-0425
Lot Number75K
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerOLYMPUS CORPORATION OF AMERICAS
Manufacturer Address3500 CORPORATE PKWY CENTER VALLEY PA 180340610 US 180340610

Device Sequence Number: 1

Brand NameOLYMPUS INJECTOR FORCE MAX SINGLE USE INJECTOR
Generic NameENDOSCOPC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
Product CodeFBK
Date Received2019-04-08
Model NumberNM-4000-0425
Lot Number75K
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS CORPORATION OF AMERICAS HEADQUARTERS
Manufacturer Address3500 CORPORATE PKWY CENTER VALLEY PA 180340610 US 180340610


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-08

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