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Model Number TJF-Q180V
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2013
Event Type  Injury  
Event Description
In (b)(6) 2013, a pt from (b)(6) received a bone marrow transplant at (b)(6).During the admission the pt had several cultures submitted and one grew a strain of carbapenem-resistant enterobacteriaceae (cre) which is reported in (b)(6) but not present in the u.S.Another pt also had a urine culture that was positive for cre but was not believed to be the same (b)(6) strain at the time.The investigation last spring initially centered on the possibility of transmission of the cre through the usual channels: index pt to another pt, index pt to staff to another pt, etc.The infection control department reported the cases to the (b)(4) department of health.Cultures from the index pt and other pt were sent to the state for testing.Internal investigation also found that the index pt and the other pt had a gi procedure done and the same endoscope was used in both cases.The endoscope was quarantined on (b)(6) 2013, while the investigation continued.The olympus ercp endoscope in use here was cultured by our epidemiology staff after standard/recommended high level disinfection.The cultures were negative for any organism.On (b)(6) 2013, the endoscope was released from quarantine and put back into use in the (b)(6) gi laboratory.The scope was again quarantined on or about (b)(6) 2013, and remains in quarantine.In (b)(6) 2013, the (b)(4)department of health notified (b)(6) of a connection between the index pt and the other pt.A list of people scoped with that particular scope, in the specified, time frame was compiled and those individuals were contacted and requested to submit to a rectal swab or to provide a stool sample.Of the 14 tested two were positive for colonization of this particular cre strain, 9 were negative and 3 refused to be tested.As of this date no pts have reported infections.Scope tested in various ways, all negative results.
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Brand Name
Type of Device
Manufacturer (Section D)
san jose CA 95131
MDR Report Key3596905
MDR Text Key21966266
Report NumberMW5033987
Device Sequence Number1
Product Code NWB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2014
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? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;