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

Catalog Number TC013

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Bleeding (1738); Surgical procedure (2357)

Event Date 08/15/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4): it was reported that the patient underwent laparascopic tubal ligation prior to the thermal ablation procedure.The patient was bleeding through the vagina from the uterus and upon laparascopic visualization of the uterus, a minor serousal bleed was noted with no perforations.

Event Description

It was reported that a patient underwent an endometrial thermal ablation procedure on (b)(6) 2014.During the procedure, the physician noted that the patient was bleeding from the uterus.A decision was made by the physician to perform a hysterectomy at that time.No additional information was provided.

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4068107
• MDR Text Key: 12445817
• Report Number: 2210968-2014-12552
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TC013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention