SINGLE USE INJECTOR NM-400U-0425

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-20 for SINGLE USE INJECTOR NM-400U-0425 manufactured by Olympus Medical Systems Corp..

Event Text Entries

[65349304] The subject device has not been returned to olympus medical systems corp. (omsc) for evaluation. The exact cause could not be conclusively determined. 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


[65349345] During a colonoscopy, the subject device was used for injection. During that, the needle tube of the subject device was not retracted into the sheath. The intended procedure was completed with another device. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5


[71022364] This is a supplemental report for mfr report # 8010047-2017-00062 to provide additional information. The subject device was returned to olympus medical systems corp. (omsc) for evaluation. The needle tube of the subject device could not be extended from the sheath. The sheath of the subject device was kinked. As the result of checking the manufacturing record of the same lot, there were nothing abnormal found. Based on the evaluation and 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 Number8010047-2017-00062
MDR Report Key6265710
Report SourceHEALTH PROFESSIONAL
Date Received2017-01-20
Date of Event2016-11-04
Date Mfgr Received2017-02-15
Device Manufacturer Date2016-04-07
Date Added to Maude2017-01-20
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 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 Received2017-01-20
Returned To Mfg2017-02-14
Model NumberNM-400U-0425
Lot NumberK6407
ID Number04953170382284
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 2017-01-20

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