SINGLE USE INJECTOR NM-400U-0423

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 2018-03-19 for SINGLE USE INJECTOR NM-400U-0423 manufactured by Olympus Medical Systems Corp..

Event Text Entries

[103169965] The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. The lot number of the subject device is unknown. As a result of checking the manufacturing record for past one year from the incident date,it was found no irregularities. This type of the event is most likely related to the operator's technique. Based on the past similar cases, it was known that the needle could not be extended out from the sheath since the frictional resistance became higher between the outer tube and the inner tube due to the kinked outer tube. The instruction manual of the device has already warned as follows; *when inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve. Otherwise, the instrument could be damaged. *always have a spare instrument available in case the primary instrument malfunctions.
Patient Sequence No: 1, Text Type: N, H10


[103169966] When the user was performing polypectomy during a colonoscopy, two nm-400u-0423 devices were used. In the procedure, the needle of the two devices could not be extended out from the sheath. Therefore, the user discontinued the procedure. There was no patient injury reported. The intended procedure was performed in another day and completed without any problem. This is the report regarding the first of the two devices.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2018-00469
MDR Report Key7348050
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-03-19
Date of Report2018-03-19
Date of Event2018-02-22
Date Mfgr Received2018-02-23
Date Added to Maude2018-03-19
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 KAZUTAKA MATSUMOTO
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO-TO 192-8507
Manufacturer CountryJA
Manufacturer Postal192-8507
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 Received2018-03-19
Model NumberNM-400U-0423
ID Number04953170382277
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-19

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