EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE UNKNOWN(SIF-Q260 OR SIF-H290S)

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 2018-11-29 for EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE UNKNOWN(SIF-Q260 OR SIF-H290S) manufactured by Olympus Medical Systems Corp..

Event Text Entries

[128724454] 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 from the facility. There was no malfunction report of the subject device concerning the events. The exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10


[128724455] On november 1, 2018, olympus medical systems corp. (omsc) received a literature titled? Treatment result of endoscopic balloon dilation (ebd) for intestinal stenosis in crohn? S disease? That was made in public in 26th japan digestive disease week. The literature reported the results and accidental symptoms in 93 procedures of ebd, which was conducted at the user facility and affiliated facility, for 29 crohn disease patients. It was also reported that the 2 cases of accidental symptom (perforation) occurred in the ebd procedures and the perforations were treated with unspecified surgery. Omsc reviewed the delivery history of the endoscopes and the history revealed that olympus small intestinal videoscopes (model sif-h290s, sif-q260) and single use splinting tube (st-sb1, st-sb1s) had been delivered to the user facility. Omsc tried to obtain additional information from the user facility, but additional information was not provided at present. Since there was no information on the model of the small intestinal videoscope that was used in the 2 cases, omsc is submitting two mdrs according to the number of reported perforation cases in small intestinal videoscope and two mdrs in splinting tube. This is one of two reports in small intestinal videoscope.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2018-02317
MDR Report Key8114263
Report SourceLITERATURE,USER FACILITY
Date Received2018-11-29
Date of Report2018-11-29
Date Mfgr Received2018-11-01
Date Added to Maude2018-11-29
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 Received2018-11-29
Model NumberUNKNOWN(SIF-Q260 OR SIF-H290S)
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 2018-11-29

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