MAUDE Adverse Event Report: OLYMPUS CORPORATION DUODENOSCOPE OLYMPUS

Model Number TJF160VF

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Date 10/19/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, ercp procedure performed using duodenoscope olympus tjfq160vf (b)(4).Scope cultured same day.Alert on preliminary positive received on (b)(6) 2017, and scope was pulled and quarantined.On (b)(6) 2017, confirmation and final result of escherichia ecoli from scope elevator.On (b)(6) 2017, escherichia coil g cultured from wound drain b (not cre).(b)(6) 2017 scope had been sent to olympus for overhaul.They would not/could not do it, so they sent it back to us.Sent to (b)(4) for overhaul and repairs.Scope was etoh sterilized by olympus.

• Brand Name: DUODENOSCOPE OLYMPUS
• Type of Device: SCOPE
• Manufacturer (Section D): OLYMPUS CORPORATION; tokyo ; JA
• MDR Report Key: 7095988
• MDR Text Key: 94207656
• Report Number: MW5073826
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• 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: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF160VF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR