MAUDE Adverse Event Report: OLYMPUS VIDEO DUODENOSCOPE

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.

• Brand Name: VIDEO DUODENOSCOPE
• Type of Device: VIDEO DUODENOSCOPE
• Manufacturer (Section D): OLYMPUS; san jose CA 95131
• MDR Report Key: 3596905
• MDR Text Key: 21966266
• Report Number: MW5033987
• Device Sequence Number: 1
• Product Code: NWB
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other