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 from a foreign,health professional,u report with the FDA on 2017-02-07 for SINGLE USE INJECTOR NM-400U-0525 manufactured by Olympus Medical Systems Corp..

Event Text Entries

[66663570] The subject device was not returned to olympus medical systems corp. (omsc). The exact cause has been under investigation. A supplemental report will be submitted, if additional and significant information becomes available at a later time.
Patient Sequence No: 1, Text Type: N, H10


[66663571] During a therapeutic endoscopy, the needle tube of the subject device could not be retracted into the sheath. No patient injury was reported. No further information.
Patient Sequence No: 1, Text Type: D, B5


[69111851] This is a supplemental report for mfr report # 8010047-2017-00130 to provide additional information. The subject device was not returned to olympus medical systems corp (omsc) for evaluation. As the result of checking the manufacturing record of the subject device, there was nothing abnormal found. The exact cause could not be conclusively determined, because the subject device was not returned. However, based on the similar cases in the past, the needle tube might be unable to retract into the sheath because the sheath was kinked. The sheath might be kinked, because excessive load was applied to the sheath when the subject device was inserted into the endoscope, it was taken out from the sterile package, or it was checked before use. The instruction manual of the subject device warns; 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. *before use, inspect the insertion portion and the tube for damage.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010047-2017-00130
MDR Report Key6306325
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-02-07
Date of Event2017-01-12
Date Mfgr Received2017-02-10
Date Added to Maude2017-02-07
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 HIROKI MORIYAMA
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO-TO
Manufacturer CountryUS
Manufacturer Phone8142642517
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSINGLE USE INJECTOR
Generic NameINJECTOR AND SHEATHSET
Product CodeFBK
Date Received2017-02-07
Model NumberNM-400U-0525
Lot Number63K
ID Number04953170259951
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US


Patients

Patient NumberTreatmentOutcomeDate
10 2017-02-07

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