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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-Q180V
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The adhesive of distal end deteriorates by chemical used in the reprocessing.Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity.Omsc guessed that the reported event was caused by aging.If additional information becomes available, this report will be supplemented.
 
Event Description
Gaps of adhesive on the light guide lens of distal end were noted.There was no report of patient injury associated with this event.
 
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Brand Name
EVIS EXERA II 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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key10513024
MDR Text Key224632739
Report Number8010047-2020-06374
Device Sequence Number1
Product Code FDT
UDI-Device Identifier04953170367311
UDI-Public04953170367311
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K143153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 09/10/2020
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 No Information
Device Model NumberTJF-Q180V
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/13/2020
Initial Date FDA Received09/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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