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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS AMERICA INC DUODENOSCOPE TJFQ180
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OLYMPUS AMERICA INC DUODENOSCOPE TJFQ180 Back to Search Results
Model Number TJFQ180
Device Problems Contamination (1120); Microbial Contamination of Device (2303)
Patient Problems Exposure to Body Fluids (1745); Death (1802); Pneumonia (2011)
Event Date 01/14/2015
Event Type  Death  
Event Description
This is one of 2 patients who had an ercp connected with scope #26, tjfq180 (b)(4).After an extensive epidemiologic and microbiologic investigation of all cre patients, a cluster of patients were identified - klebsiella pneumonia.These were highly related to each other suggesting a common source.Further investigation determined that the procedure ercp was highly related.Ercps performed between an approximate three month time frame.Two of the 8 patients were related to scope tjfq180 (b)(4).
 
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Brand Name
DUODENOSCOPE TJFQ180
Type of Device
DUODENOSCOPE
Manufacturer (Section D)
OLYMPUS AMERICA INC
3500 corporate pkwy
center valley PA 18034
MDR Report Key5666107
MDR Text Key45489575
Report Number5666107
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2016
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Model NumberTJFQ180
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2016
Event Location Hospital
Date Report to Manufacturer05/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
THE PT HAD A PRIOR ERCP PERFORMED BUT IT WAS SCOP
Patient Outcome(s) Death; Hospitalization; Life Threatening; Required Intervention;
Patient Age61 YR
Patient Weight107
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