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

Model Number NS2000

Device Problem Overheating of Device (1437)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 02/04/2016

Event Type  Injury  

Manufacturer Narrative

The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.(b)(4).

Event Description

It was reported a physician performed a novasure endometrial ablation on (b)(6) 2016.A laparoscopy was performed and the physician noted a full thickness burn to the sigmoid colon.Sigmoid colectomy with primary end-end anastomosis.The small bowel was inspected in its entirety through a pfannenstiel incision.Two small superficial diathermy burns were over sewn with 3/0 pds.Two more extensive small bowel burns were excised and repaired transversely with 3/0 pds interrupted sutures.The patient was admitted into the hospital.It is unknown when she was discharged.Was seen on follow up and doing fine.

• Brand Name: NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
• Type of Device: UTERINE ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 5485646
• MDR Text Key: 39902314
• Report Number: 1222780-2016-00051
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: NS2000
• Device Catalogue Number: 915002-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR