MAUDE Adverse Event Report: HOLOGIC NOVASURE IMPEDANCE CONTROLLED EA SYSTEM; UTERINE ABLATION DEVICE

Model Number NS2000

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 04/04/2014

Event Type  Injury  

Event Description

It was reported the physician completed a novasure endometrial ablation on (b)(6) year old g2p2 pt with no signification past medical or surgical history.She had a history of abnormal uterine bleeding.The pt desired permanent contraception and was scheduled for a laparoscopic tubal sterilization at the time of the novasure ablation.The device was placed without difficulty into the uterine cavity and seated to a width of 4.3cms.After completing the ablation, the device was removed without difficulty and the dr.Performed a laparoscopy.At laparoscopy, he identified bilateral circumferential thermal burns on the serosa of the uterine surface medial to each cornual region.After completing a bilateral salpingectomy in addition to cauterization and resection of endometriotic implants, a general surgeon was consulted for inspection of the bowel.Two areas on the small bowel were identified consistent with thermal injury.There were two other areas which were also suspicious for injury.A bowel resection was performed with end-to-end anastomosis.The pt was admitted to the hospital and remained stable with uncomplicated post-operative course.

Manufacturer Narrative

The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and eval completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the disposable novasure device and the radio frequency controller.Both devices were released meeting all qa specifications.Currently unable to establish a relationship or impact to the reported observation.(b)(4).

• Brand Name: NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
• Type of Device: UTERINE ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 3800266
• MDR Text Key: 4527714
• Report Number: 1222780-2014-00073
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: NS2000
• Device Catalogue Number: 915002-01
• Device Lot Number: 13K30RC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RADIO FREQUENCY CONTROLLER - 31356J10D0
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR