SINGLE USE INJECTOR NM600/610 NM-600L-0521

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 2018-10-18 for SINGLE USE INJECTOR NM600/610 NM-600L-0521 manufactured by Olympus Medical Systems Corp..

Event Text Entries

[124666282] The subject device was not returned to olympus medical systems corp. (omsc) for evaluation, because the subject device was discarded by the user. Therefore, the exact cause of the reported event could not be conclusively determined. The manufacturing record was reviewed and found no irregularities. This type of the event is most likely related to the operator's technique. Based on the past similar cases, omsc presumes that the event occurred due to either of the following possible causes. 1) the bending of the tube occurred due to applying bending load to the tube when the device was inserted into the endoscope. The frictional resistance between the tube and the needle tube increased due to the bending of the tube. The needle could not be retracted into the tube. 2) the bending of the tube occurred due to applying bending load to the tube when the device was inserted into the endoscope. The frictional resistance between the tube and the needle tube increased due to the bending of the tube. The jointing part of the needle tube slipped toward the distal end when the slider was pulled. The needle could not be retracted into the tube. The instruction manual of the device has already warned as follows; a) 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. B) stop using the instrument if the insertion portion bends excessively during use. This could result in malfunction, such as failing to extend the needle or inject a fluid.
Patient Sequence No: 1, Text Type: N, H10


[124666283] During a hemostasis for gastric varices bleeding, the subject device was used. Although the user tried to retract the needle of the subject device, the needle could not be retracted into the tube. The user removed the subject device and endoscope from the patient. The intended procedure was completed. No patient injury was reported. This is the report regarding the inability to retract the needle.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2018-02007
MDR Report Key7976997
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-10-18
Date of Report2018-10-18
Date of Event2018-10-03
Date Mfgr Received2018-10-03
Date Added to Maude2018-10-18
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 NM600/610
Generic NameINJECTOR AND SHEATHSET
Product CodeFBK
Date Received2018-10-18
Model NumberNM-600L-0521
Lot Number65K
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 2018-10-18

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