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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS DUODENOSCOPE; ERCP SCOPE
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OLYMPUS DUODENOSCOPE; ERCP SCOPE Back to Search Results
Model Number TJF160VF
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2015
Event Type  malfunction  
Event Description
On (b)(6) 2015, patient underwent an ercp.During procedure, a plastic pancreatic duct stent manufactured by boston labs was retrieved from an olympus scope.The retained object was removed from the scope and sequestered as was the scope.Upon further investigation, it was determined that this stent was retained in the scope since its use on (b)(6) 2015 on another patient.Upon further investigation, it was determined that in addition to this patient that was exposed on (b)(6) 2015, there have been five other patients who have used this same scope since (b)(6) 2015.The scope has been cleaned and sterilized according to manufacturer's recommendations each time it was used.The following are a list of the other patients that have had the scope used on them since the source patient on (b)(6) 2015: (b)(6).The patient with identifying information of mrn: (b)(6) was admitted to hospital on (b)(6) 2015 with painless obstructive jaundice.No significant other medical history.
 
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Brand Name
DUODENOSCOPE
Type of Device
ERCP SCOPE
Manufacturer (Section D)
OLYMPUS
center valley PA 18034
MDR Report Key5018853
MDR Text Key23643766
Report NumberMW5055595
Device Sequence Number1
Product Code FDT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Report Date 08/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2015
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTJF160VF
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NONE NOTED.
Patient Outcome(s) Other;
Patient Age70 YR
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