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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 SIF-Q260
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Type  Injury  
Manufacturer Narrative
The subject device was not been returned to 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 titled ¿usefulness of biliary and pancreatic treatment endoscopy in cases after gastrointestinal tract surgery¿. The literature reported the result of 72 patients who underwent endoscopic retrograde cholangiopancreatography (ercp) for after gastrointestinal tract surgery between january 2008 and december 2018. There was no detailed information on which model of the endoscope was used in each procedure. The literature only provided a part of model names, ¿q260j¿, ¿jf¿, ¿pcf¿, ¿sif¿ and ¿h290¿. However, omsc presumed based on a delivery record that these models were gif-q260j, jf-260v, pcf-q260ji, sif-q260 and gif-h290. In the subject procedures, 1 case of small intestinal mucosal tear, 1 case of small intestinal perforation requiring emergency surgery, and 1 case of duodenal perforation reportedly occurred. Based on the available information, the small intestinal mucosal tear and the small intestinal perforation requiring emergency surgery were associated with endoscopic insertion. However, a direct relationship between the endoscopes and the duodenal perforation could not be determined. This is 1 of 3 reports for the sif-q260 which may involved in the small intestinal mucosal tear.
 
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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 Key8779524
MDR Text Key150717733
Report Number8010047-2019-02510
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 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
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 Received06/13/2019
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: 07/11/2019 Patient Sequence Number: 1
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