On (b)(6) 2013, user facility reported an event as follows: patient underwent an endoscopic retrograde cholangiopancreatography (ercp) procedure (date unknown) and developed a carbapenem-resistant enterobacteriaceae (cre) infection.
The patient received antibiotics.
No further information is available at this point about the patient.
(b)(4) found behind elevator on scope.
During a conference call with advocate on (b)(6) 2013 pentax was informed that one patient developed carbapenem-resistant enterobacteriaceae (cre) infection after undergoing ercp procedures using scope ed-3490tk, a110574.
Additional twelve patients were screened for cre; nine patients screened negative and 3 patients screened positive for cre but did not develop a cre infection.
The scope was tested at the user facility and positive culture was found behind the elevator and through the hole of the scope.
Customer confirmed that non-pentax brushes are used to manually reprocess the pentax scopes.
The cleaning brushes used at the facility are medivators.
In addition, surg-enz is the enzymatic detergent/cleaner used to reprocess the scopes and is not on the pentax approved list of detergents.
Cidex opa is used for high level disinfection.
According to the pentax reprocessing/maintenance instruction for use (ifu), it specifically states that user must "be aware that all recessed areas around the elevator mechanism should be thoroughly cleaned with an appropriately sized cylinder cleaning brush (e.
G.
Csc9s) and in a cleaning detergent solution.
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