THERMACHOICE R20517 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-05 for THERMACHOICE R20517 * manufactured by Ethicon, Inc..

Event Text Entries

[17996307] Both single use thermachoice devices failed to maintain the pressure needed to begin cycle. The device was connected to thermachoice machine. When removed from the uterus we observed that there was no balloon leak. No therapy cycle attempted. Novasure handpiece was brought in and the device would not open when inside the uterine cavity. It did open completely when tested outside of the patient. The device was never connected to novasure generator. No therapy cycle was attempted. Dilation and curettage hysteroscopy was performed - no pictures taken. Tissue specimen was sent to pathology. Both single use devices were placed in a red bag and labeled. Thermachoice generator was sequestered.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	4143563
MDR Report Key	4143563
Date Received	2014-09-05
Date of Report	2014-09-05
Date of Event	2014-08-28
Report Date	2014-09-05
Date Reported to FDA	2014-09-05
Date Reported to Mfgr	2014-10-06
Date Added to Maude	2014-10-06
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
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 Details

Brand Name	THERMACHOICE
Generic Name	CATHETER, BALLOON, TRANSCERVICAL
Product Code	MKN
Date Received	2014-09-05
Model Number	R20517
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	Y
Device Sequence No	1
Device Event Key	0
Manufacturer	ETHICON, INC.
Manufacturer Address	ROUTE 22 WEST P O BOX 151 SOMERVILLE NJ 08876015 US 08876 0151

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-09-05