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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number TJF-Q180V
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2020
Event Type  malfunction  
Event Description
The patient was undergoing endoscopic retrograde cholangiopancreatography when the duodenoscope was in pt at the ampulla, about to cannulate the bile duct.No interventions had been performed yet with the duodenoscope.The sphincterotome was passed through the scope and the md felt resistance was met while trying to push the sphincterotome through the channel.Then a portion of an old stent was noted on the scope screen.The scope was immediately removed from the patient and it was noted that an old stent from some previous pt/procedure was stuck in the scope and never came out during scope processing.The scope was sequestered and given to scope processing, evening shift supervisor.
 
Event Description
The patient was undergoing endoscopic retrograde cholangiopancreatography when the duodenoscope was in pt at the ampulla, about to cannulate the bile duct.No interventions had been performed yet with the duodenoscope.The sphincterotome was passed through the scope and the md felt resistance was met while trying to push the sphincterotome through the channel.Then a portion of an old stent was noted on the scope screen.The scope was immediately removed from the patient and it was noted that an old stent from some previous pt/procedure was stuck in the scope and never came out during scope processing.The scope was sequestered and given to scope processing, evening shift supervisor.
 
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Brand Name
EVIS EXERA II DUODENOVIDEOSCOPE
Type of Device
DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
136 turnpike road
southborough MA 01772
MDR Report Key9852970
MDR Text Key184082081
Report Number9852970
Device Sequence Number1
Product Code FDT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 03/10/2020,02/25/2020
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 Health Professional
Device Model NumberTJF-Q180V
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/10/2020
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer03/19/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/19/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age23360 DA
Patient Weight103
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