MAUDE Adverse Event Report: PENTAX PENTAX; ERCP SCOPE

Model Number ED-3490TK

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2015

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 pt is at risk for potential exposure to the organism.This ercp scope (b)(4) was in use at our hosp from (b)(6) 2015.

• Brand Name: PENTAX
• Type of Device: ERCP SCOPE
• Manufacturer (Section D): PENTAX
• MDR Report Key: 4771518
• MDR Text Key: 16862904
• Report Number: MW5042676
• 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
• 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: 45 YR