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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 Positioning Problem (3009)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the service center for evaluation.The customer¿s complaint of the ¿ forceps elevator not moving¿ was confirmed.The movement of the forceps elevator was found rough.The bending section glue was found cracked on the insertion tube.Minor dents were noted on control body plastic cover.The scope was repaired and to the customer.The content of this complaint will be reviewed by the legal manufacturer for further investigation.
 
Event Description
The service center was informed that during preparation for use, the forceps elevator on the scope would not move up or down.There was no patient involvement 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 if the malfunction were to recur.
 
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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 Key11090126
MDR Text Key224161962
Report Number8010047-2020-11086
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 user facility
Type of Report Initial,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2020
Was the Report Sent to FDA? No
Date Manufacturer Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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