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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III DUODENOVIDEOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III DUODENOVIDEOSCOPE Back to Search Results
Model Number TJF-Q190V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Arrest (1762)
Event Date 06/03/2021
Event Type  Injury  
Event Description
It is reported during an endoscopic retrograde cholangiopancreatography (ercp) using an evis exera iii duodenovideoscope, the patient coded (cardiac arrest).There was no mucosa present in distal cap or in the elevator channel upon withdrawal of the scope.It was unknown if there was any internal injury to the patient.The patient was taken to the intensive care unit at the facility for treatment.There was no report of device malfunction.The physician stated that the issue was likely patient related, and not related to the scope.Additional details regarding the patient and reported event have been requested.At this time, no information has been provided.
 
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Brand Name
EVIS EXERA III 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 Key12092322
MDR Text Key259189252
Report Number2951238-2021-00354
Device Sequence Number1
Product Code FDT
UDI-Device Identifier04953170405563
UDI-Public04953170405563
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2021,06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberTJF-Q190V
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date06/03/2021
Event Location Hospital
Date Report to Manufacturer06/03/2021
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
MAJ-2315
Patient Outcome(s) Life Threatening; Other;
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