MAUDE Adverse Event Report: ETHICON, INC. THERMACHOICE; DEVICE, THERMAL ABLATION

Catalog Number TC003

Device Problem Decrease in Pressure (1490)

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

Event Date 03/18/2014

Event Type  malfunction  

Event Description

Thermachoice ablation disposable instrument could not hold pressure.It is the type with fluid circulation.

• Brand Name: THERMACHOICE
• Type of Device: DEVICE, THERMAL ABLATION
• Manufacturer (Section D): ETHICON, INC.; rt. 22 west; p.o. box 151; somerville NJ 08876 015
• MDR Report Key: 3694697
• MDR Text Key: 4249667
• Report Number: 3694697
• Device Sequence Number: 1
• Product Code: MNB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: TC003
• Device Lot Number: H206TC0031
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2014
• Patient Sequence Number: 1