UNKNOWN

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 2018-06-07 for UNKNOWN manufactured by Olympus Medical Systems Corp..

Event Text Entries

[110337339] The subject device has not been returned to olympus medical systems corp (omsc). Omsc could not review the service and manufacturing record because the serial number was not provided by the facility. The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10


[110337340] On may 11, 2018, olympus received literature titled? A study of single-balloon endoscopic treatment for pancreatic biliary tract disease associated with patients having reconstructed gastrointestinal anatomy in our hospital.? That was made in public in japan digestive disease week (jddw). The literature reported the result of 27 cases of the endoscopic treatment using olympus single balloon enteroscope between april 2008 to october 2017. In the procedures, following accidental symptoms reportedly occurred. Pancreatitis: 4 cases, bile duct inflammation: 1 case, micro perforation: 3 cases, aspiration pneumonia: 1 case, three cases of perforation improved by conservative medical treatment. Olympus reviewed the delivery history of endoscopes for the facility and confirmed olympus sif-h290s, sif-y0004-v01, sif-y0015, and sif-q260 were delivered. Olympus is submitting mdr according to the number of accidental symptoms case because it was not informed that which endoscope model was used in the procedures. This report is 8 of 9 reports.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2018-01036
MDR Report Key7576778
Report SourceLITERATURE,USER FACILITY
Date Received2018-06-07
Date of Report2018-06-07
Date Mfgr Received2018-05-11
Date Added to Maude2018-06-07
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 NameUNKNOWN
Generic NameSMALL INTESTINAL VIDEOSCOPE
Product CodeFDA
Date Received2018-06-07
Model NumberUNKNOWN
Lot NumberUNKNOWN
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 2018-06-07

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