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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEO SCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEO SCOPE Back to Search Results
Model Number SIF-H290S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
Olympus medical systems corp. (omsc) received a literature title therapeutic peroral direct cholangioscopy using a single balloon enteroscope in patients with roux-en-y anastomosis (with videos). The literature reported the result of 169 cases of the peroral direct cholangioscopy (pdcs) using single-balloon enteroscope (sbe) procedures using an olympus model small intestinal video scope, sif-h290s and sif-y0015 between november, 2012 and november, 2016. In the subject procedures, 1 case of pancreatitis reportedly occurred. Based on the available information, a direct relationship between the subject devices and the observed reported adverse event could not be determined. According to the number of the accidental symptoms known and the number of olympus devices used for procedure, omsc is submitting 2 medical device reports. This is 1st of 2 reports.
 
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Brand NameEVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE
Type of DeviceSMALL INTESTINAL VIDEO SCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9881982
MDR Text Key196474711
Report Number8010047-2020-01867
Device Sequence Number1
Product Code FDA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSIF-H290S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/26/2020 Patient Sequence Number: 1
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