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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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE Back to Search Results
Model Number SIF-Q260
Device Problem Insufficient Information (3190)
Patient Problem Laceration(s) (1946)
Event Type  Injury  
Manufacturer Narrative
There was no malfunction report of the subject device associated to the accidental symptoms. Since the serial number of this device was not informed, olympus medical systems corp. (omsc) could not confirm the manufacturing history. Although the user facility recognized the events as accidental symptoms in the literature, the exact cause of the reported event could not be conclusively determined.
 
Event Description
On (b)(6) 2018, olympus medical systems corp. Received a literature titled ¿the study of short single balloon endoscope (s-sbe) vs single balloon endoscope (sbe) in ercp of postoperative reconstructed intestinal tract cases¿ that was made in public in 95th congress of the (b)(6) gastroenterological endoscopy society on (b)(6) 2018. Accidental symptoms after the procedures of endoscopic retrograde cholangiopancreatography (ercp) of postoperative reconstructed intestinal tract cases using olympus small intestinal videoscope (sif-h290s and sif-q260) were reported in the literature. The literature evaluated the ercp for postoperative reconstructed intestinal tract cases and compared the results of s-sbe with sbe. The target procedures of ercp of postoperative reconstructed intestinal tract cases were carried out between (b)(6) 2012 and (b)(6) 2017, and the number of cases was 115. In the subject procedures, accidental symptoms occurred as follows. S-sbe (sif-h290s): pancreatitis 3 cases, cholangitis 1 case sbe (sif-q260): gastrointestinal perforation 1 case, mucosal laceration 2 cases, pancreatitis 2 cases, cholangitis 1 case. Omsc is submitting 10 medical device reports considering the number of accidental symptoms. This is 6th of 10 reports. (sbe (sif-q260): mucosal laceration 1st of 2 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 Key7572294
MDR Text Key110171978
Report Number8010047-2018-01003
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 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSIF-Q260
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

Patient Treatment Data
Date Received: 06/06/2018 Patient Sequence Number: 1
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