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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE Back to Search Results
Model Number UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Not Applicable (3189)
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
On may 11, 2018, olympus medical systems corp. (omsc) received a literature titled ¿study on ercp (endoscopic retrograde cholangiography) using short- type single balloon endoscope(sbe) for patients who experienced rouen-y intestinal reconstructive surgery¿. The literature reported the result of the 19 procedures of the ercp which were conducted between july 2016 and september 2017 at the user facility. In the 19 procedures, an olympus small intestinal videoscope sif-h290s was used. (however, in two of 19 procedure, olympus sif-q260 was used following the sif-h290s since the sif-h290s could not reach the target sites). The literature reported 3 case of mild pancreatitis as accidental symptoms related to the ercp procedures. In one of the 3 case of perforation, sif-h290s was apparently used. In the other two cases of perforation, sif-h290s and sif-q260 were possibly used. However, it was uncertain of whether the two scope were actually used in the two cases, and which scope attributed to the two perforations. According to the three accidental symptoms cases, omsc is submitting one medical device report (mdr) associated with sif-h290s and two mdrs associated with unspecified small intestine videoscope. This is one of three reports.
 
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Brand NameEVIS LUCERA SMALL INTESTINAL VIDEOSCOPE
Type of DeviceSMALL INTESTINAL VIDEOSCOPE
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 Key7581031
MDR Text Key110467908
Report Number8010047-2018-01063
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,user facility
Reporter Occupation
Type of Report Initial
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
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 Received05/11/2018
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: 06/07/2018 Patient Sequence Number: 1
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