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

Catalog Number TC013

Device Problems Overheating of Device (1437); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2015

Event Type  malfunction  

Event Description

During procedure, the device overheated and the machine shut itself off.A new procedure kit was used and the procedure was done without further incident.No harm to patient or health care worker or doctor.

• Brand Name: THERMACHOICE III
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): ETHICON, INC.; rt. 22 west; p.o. box 151; somerville NJ 08876
• MDR Report Key: 5177068
• MDR Text Key: 29225520
• Report Number: 5177068
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: TC013
• Device Lot Number: JCMG05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2015
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN AT THIS TIME
• Patient Age: 38 YR