EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE 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 2018-11-30 for EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE UNKNOWN manufactured by Olympus Medical Systems Corp..

Event Text Entries

[128881495] The subject device was 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 from 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


[128881496] Olympus medical systems corp. (omsc) received a literature titled? Study on bowel endoscopic ercp (be-ercp) using small intestinal scope in the bile duct stone for the elderly patients who experienced intestinal reconstructive surgery? That was made in public in 26th japan digestive disease week (jddw). The literature reported the result of the be-ercp procedures for bile duct stones in 189 cases for the elderly patients and the procedures were conducted between november 2008 and january 2018 at user facility. In the procedures, pancreatitis (1. 2%: over 75 years, 1. 9%: under 75 years), perforation (4. 7%: over 75 years, 3. 8%: under 75 years), bleeding (1. 2%: over 75 years, 1. 9%: under 75 years) and respiratory failure (0%: over 75 years, 1. 0%: under 75 years) as accidental symptom reportedly occurred. In the jddw, it was also reported that olympus small intestinal videoscope model sif-q260 or sif-h290s were used in the procedures. Omsc tried to obtain detailed information, but additional information was not obtained. Omsc is submitting mdr according to the number of types of the accidental symptom. This is 3 of 4 reports.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2018-02330
MDR Report Key8118700
Report SourceLITERATURE,USER FACILITY
Date Received2018-11-30
Date of Report2018-11-30
Date Mfgr Received2018-11-02
Date Added to Maude2018-11-30
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 SMALL INTESTINAL VIDEOSCOPE
Generic NameSMALL INTESTINAL VIDEOSCOPE
Product CodeFDA
Date Received2018-11-30
Model NumberUNKNOWN
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 2018-11-30

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