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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Laceration(s) of Esophagus (2398); Blood Loss (2597); Thrombosis/Thrombus (4440)
Event Date 11/27/2020
Event Type  Injury  
Event Description
It is reported during an endoscopic retrograde cholangiopancreatography (ercp) using an olympus duodenoscope, blood was noted in stomach upon withdrawal of the ercp scope.An esophagogastroduodenal (egd) scope was advanced where a blood clot was visualized in the hiatal hernia.A small tear was found at the gastro esophageal junction/proximal stomach.Two clips were placed.There was no malfunction of the tjf-q180v.The patient remained stable and pain-free following the procedure.The patient was discharged to a skilled nursing facility 6 days post ercp.
 
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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 Key11059972
MDR Text Key223375120
Report Number2951238-2020-00528
Device Sequence Number1
Product Code FDT
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 11/27/2020,12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberTJF-Q180V
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/27/2020
Event Location Hospital
Date Report to Manufacturer11/27/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age94 YR
Patient Weight76
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