MAUDE Adverse Event Report: PENTAX PENTAX; ERCP SCOPE

Model Number ED-3490TK

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Date 04/10/2015

Event Type  Injury  

Event Description

After appropriate cleaning, and high level disinfection routine culturing on the device elevator produced a positive result for carbapenem-resistant enterobacteriaceae (cre).This patient is at risk for potential exposure to the organism.

• Brand Name: PENTAX
• Type of Device: ERCP SCOPE
• Manufacturer (Section D): PENTAX
• MDR Report Key: 4771501
• MDR Text Key: 5792954
• Report Number: MW5042672
• Device Sequence Number: 1
• Product Code: FBN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ED-3490TK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR