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

Catalog Number TC043

Device Problem Balloon leak(s) (1052)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an endometrial thermal ablation procedure on (b)(6) 2015.During therapy, a leak was noted from the balloon.Another like device was used.There were no adverse patient consequences reported.

Manufacturer Narrative

(b)(4).Conclusion: the actual device involved in this event was returned for evaluation.The device was visually and functionally evaluated.Upon evaluation, the device did not maintain pressure because one pinhole was found on the balloon.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.(b)(4).

• Brand Name: GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: mary szaro ; 9082183464
• MDR Report Key: 4973593
• MDR Text Key: 6373532
• Report Number: 2210968-2015-10872
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• PMA/PMN Number: P970021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2016
• Device Catalogue Number: TC043
• Device Lot Number: HPMG04
• Other Device ID Number: 10705031050761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1