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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SIF-Y0004-V01 SMALL INTESTINAL VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. SIF-Y0004-V01 SMALL INTESTINAL VIDEOSCOPE Back to Search Results
Model Number SIF-Y0004-V01
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 titled ¿the usefulness of endoscopic treatment for intrahepatic stone disease¿. The literature reported the result of 57 cases of the treatment for intrahepatic calculosis procedures between 2003 and 2018. There was a possibility that sbe-ercp (single balloon enteroscopy - endoscopic retrograde cholangiopancreatography) was performed using the sif-y0004-v01. In this literature, it was reported adverse events as follows after the procedures; cholangitis occurred in 3 cases. Recurrence of intrahepatic stone disease occurred in 4 cases. Liver abscess occurred in 1 case. Bile duct cancer occurred in 1 case. Based on the available information, a direct relationship between the subject device and the reported adverse events could not be determined. Omsc is submitting nine mdrs according to the number of the adverse events. This is 1 of 9 reports. (1 of 3 cholangitis cases).
 
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Brand NameSIF-Y0004-V01
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 Key9494353
MDR Text Key188855624
Report Number8010047-2019-04455
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 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSIF-Y0004-V01
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 Received11/21/2019
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: 12/19/2019 Patient Sequence Number: 1
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