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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS EVIS EXERA II (TJF-Q180V); ERCP SCOPE
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OLYMPUS EVIS EXERA II (TJF-Q180V); ERCP SCOPE Back to Search Results
Model Number TJF-Q180V
Device Problems Device Disinfection Or Sterilization Issue (2909); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems Bacterial Infection (1735); Death (1802)
Event Date 12/12/2014
Event Type  Death  
Event Description
Pt underwent ercp for pancreatitis on (b)(6).Unfortunately, pt developed bacteremia with carbapenem resistant klebsiella soon afterwards.After investigation by clinical epidemiology and infection prevention (and eventually the (b)(6)) it was determined that this pt was the index case in an outbreak of cre after ercp (total of 8 patients thus far).The scopes were cleaned in accordance to the mfr's guidelines and no defects were found in the processing of the scopes or the scopes themselves.We believe, based on our investigation, that the infection were the result of inadequate cleaning guidelines from the scope mfr or a scope design flaw that does not allow us to clean these scopes adequately despite recommended processing.Dates of use: (b)(6) 2014.Diagnosis or reason for use: pancreatitis.(b)(4).
 
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Brand Name
EVIS EXERA II (TJF-Q180V)
Type of Device
ERCP SCOPE
Manufacturer (Section D)
OLYMPUS
center valley PA 18034
MDR Report Key4538861
MDR Text Key5512708
Report NumberMW5040805
Device Sequence Number1
Product Code FDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 02/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2015
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age41 YR
Patient Weight40
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