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

Catalog Number TC003

Device Problem Overheating of Device (1437)

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

Event Date 02/12/2014

Event Type  malfunction  

Event Description

The thermachoice balloon device was opened and was connected to machine and device was primed and ready per surgical tech and physician.The balloon was inserted into uterus and the machine failed saying overheated.The device was removed from field and a new disposable balloon device was opened.No errors noted on this setup.Procedure continued with no problems.No harm noted to patient.

• Brand Name: THERMACHOICE
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): ETHICON, INC.; route 22 west; p o box 151; somerville NJ 08876 015
• MDR Report Key: 3904335
• MDR Text Key: 4678116
• Report Number: 3904335
• 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
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: TC003
• Device Lot Number: GLMG13
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2014
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 85