EVIS LUCERA DUODENOVIDEOSCOPE JF-260V

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature,user facility report with the FDA on 2020-03-06 for EVIS LUCERA DUODENOVIDEOSCOPE JF-260V manufactured by Olympus Medical Systems Corp..

Event Text Entries

[182470982] The subject device was not returned to olympus medical systems corp (omsc). The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined. If additional information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10


[182470983] Olympus medical systems corp. (omsc) received a literature titled? Natural history of asymptomatic bile duct stones and association of endoscopic treatment with clinical outcomes?. The literature reported the result of 77 cases of the early endoscopic stone removal of asymptomatic stones procedures using olympus duodenovideoscope model jf-260v or tjf-260v or non-olympus endoscope from january 2010 to march 2018. In the subject cases, 3 case of bleeding, 3 cases of aspiration pneumonia and 1 case of gastrointestinal perforation occurred. Based on the available information, a direct relationship between the olympus products and the observed adverse events could not be determined. Therefore, omsc will submit 14 medical device reports (mdr) depending on the type of device and number of adverse events. This report is 4 of 14 reports for aspiration pneumonia (1 of 3) at jf-260v.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2020-01673
MDR Report Key9796973
Report SourceLITERATURE,USER FACILITY
Date Received2020-03-06
Date of Report2020-03-06
Date Mfgr Received2020-02-13
Date Added to Maude2020-03-06
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 NameEVIS LUCERA DUODENOVIDEOSCOPE
Generic NameDUODENOVIDEOSCOPE
Product CodeFDT
Date Received2020-03-06
Model NumberJF-260V
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
101. Other 2020-03-06

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