ETHICON GYNECARE THERMACHOICE 2 EAS2000-1 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-11 for ETHICON GYNECARE THERMACHOICE 2 EAS2000-1 * manufactured by Ethicon, Inc..

Event Text Entries

[2351774] After hooking up the ablation catheter and testing the ethicon gynecare thermachoice machine prior to using on the patient, the machine delivered a message, "error 5506. " a new catheter was tried, from the same lot, and the same message appeared after testing. The ethicon technician was called and stated that "error 5506" message indicated that there was an internal component issue and to take the machine out of service. This was done and the procedure was aborted. ======================manufacturer response for thermal balloon catheter, ghyecare thermachoice iii uterine balloon catheter (per site reporter). ======================no response. Feels issue is with the machine.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2344268
• MDR Report Key: 2344268
• Date Received: 2011-11-11
• Date of Report: 2011-11-11
• Date of Event: 2011-11-09
• Report Date: 2011-11-11
• Date Reported to FDA: 2011-11-11
• Date Added to Maude: 2011-11-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ETHICON GYNECARE
• Generic Name: THERMAL ABLATION MACHINE
• Product Code: MNB
• Date Received: 2011-11-11
• Model Number: THERMACHOICE 2 EAS2000-1
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ETHICON, INC.
• Manufacturer Address: ROUTE 22 WEST SOMERVILLE NJ 08876015 US 08876 0151

Device Sequence Number: 2

• Brand Name: GHYECARE THERMACHOICE III UTERINE BALLOON CATHETER
• Generic Name: THERMAL BALLOON CATHETER
• Product Code: MKN
• Date Received: 2011-11-11
• Model Number: *
• Catalog Number: TC003
• Lot Number: DBMG03
• ID Number: *
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ETHICON, INC.
• Manufacturer Address: ROUTE 22 WEST SOMERVILLE NJ 08876015 US 08876 0151

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-11-11