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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 Date 10/27/2020
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
Olympus medical systems corp.(omsc) was informed from the user that during the preparation for use, the forceps elevator of the subject device could not be moved.The procedure was canceled.The field service engineer of olympus (b)(4) confirmed the reported issue at the facility.Olympus (b)(4) checked the subject device and found that there was the gap on the adhesive of the distal end.There was no report of patient injury associated with the event.
 
Manufacturer Narrative
This supplemental report is being submitted to report the withdrawal of mfr report #8010047-2020-09364 and correct the initial report submitted on nov 24, 2020.As a result of the investigation, olympus medical systems corp.(omsc) concluded that this complaint was not reportable event because it was found that the reported phenomenon had not occurred resulting from the investigation.
 
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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
MDR Report Key10893896
MDR Text Key217967673
Report Number8010047-2020-09364
Device Sequence Number1
Product Code FDT
UDI-Device Identifier04953170367311
UDI-Public04953170367311
Combination Product (y/n)N
PMA/PMN Number
K143153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/19/2021
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 NumberTJF-Q180V
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/24/2020
Supplement Dates Manufacturer Received12/18/2020
Supplement Dates FDA Received01/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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