Olympus was informed that five pts tested positive for carbenepenum resistant enterbacteriaceae containing new delhi metallo-beta-lactamase (cre-ndm) after having undergone an endoscopic retrograde cholangiopancreatography (ercp) procedure.
The pts were examined with the same duodenovideoscope.
On (b)(6) 2013, the fifth pt underwent an ercp with biliary sphincterotomy and biliary metal stent placement and subsequently developed bile duct and pancreatic duct dilation, and postprandial abdominal pain.
The pt was hospitalized for an unspecified amount of time.
Since (b)(6) 2013, the pt has been receiving outpatient chemotherapy.
On (b)(6) 2013, rectal swab from the pt tested positive for cre-ndm.
On (b)(6) 2014, the pt was admitted with intractable nausea and vomiting.
An endoscopy support specialist was dispatched to the user facility.
A reprocessing in-service has not been scheduled to date.
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The device has not been yet returned for evaluation.
The exact cause of the user's experience could not be conclusively determined at this time.
A supplemental report will be submitted if additional and significant information becomes available later.
Please cross-reference the following reports for the other four pts: 2951238-2014-00023, 2951238-2014-00024, 2951238-2014-00025 and 2951238-2014-00026.
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