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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE Back to Search Results
Model Number SIF-Q180
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device has been returned for evaluation.The customer¿s complaint of the leak issue was confirmed.The service technician observed leaking from the a-rubber glue.Passed regulated air line test.The cause can be attributed to component failure.No further information was reported.
 
Event Description
The customer reported to olympus that the device failed leak test several times.There was no patient injury reported.
 
Manufacturer Narrative
Upon further review this is not a reportable malfunction.  per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury. .
 
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Brand Name
EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
Type of Device
SMALL INTESTINAL VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10260824
MDR Text Key223651951
Report Number8010047-2020-04165
Device Sequence Number1
Product Code FDA
UDI-Device Identifier04953170237423
UDI-Public04953170237423
Combination Product (y/n)N
PMA/PMN Number
K071254
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSIF-Q180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/16/2020
Initial Date FDA Received07/10/2020
Supplement Dates Manufacturer Received08/05/2020
Supplement Dates FDA Received08/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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