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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA DUODENOVIDEOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-160VR
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
 
Event Description
Some of the wires that composes the forceps elevator wire of the subject device was cut and raised.There was no report of patient injury associated with this event.
 
Manufacturer Narrative
The subject device was returned to olympus europa se & co.Kg (oekg) for evaluation.Evaluation of the subject device confirmed the followings; omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Cut of some of the wires that composes the forceps elevator wire of the subject device was noted.When a distal end cover was attached to this device, the frayed wires were covered by it and were not exposed.Omsc assumed that the reported event was caused by aging.If additional information becomes available, this report will be supplemented.
 
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Brand Name
EVIS EXERA DUODENOVIDEOSCOPE
Type of Device
DUODENOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10198298
MDR Text Key213253447
Report Number8010047-2020-03659
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
PMA/PMN Number
K024033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberTJF-160VR
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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