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

Model Number NS2000

Device Problem Overheating of Device (1437)

Patient Problems Abdominal Pain (1685); Bowel Perforation (2668); Fluid Discharge (2686)

Event Date 12/15/2013

Event Type  Injury  

Event Description

It was reported by the patient that a physician performed a novasure endometrial ablation on (b)(6) 2013 and she was discharged home.On (b)(6) 2013, the patient was experiencing "lower abdominal pain".The pain started to increase and she presented to the emergency room.A computed tomography (ct) scan was performed and revealed "free fluid along with intro-abdominal free air".The physician then performed a laparoscopy which revealed a small bowel perforation and thermal injury.A small bowel resection was performed.The discharged date is unk.And "the patient is ok".

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant, therefore, the expiration date is not known.Serial number of the radio frequency controller not provided by the complainant.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore, the manufacturer date is not known.Device history record (dhr) review was unable to be conducted for the disposable device as the lot number was not provided by the complainant.If additional relevant info is received, a supplemental medwatch will be filed.(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: 4089859
• MDR Text Key: 4721436
• Report Number: 1222780-2014-00152
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NS2000
• Device Catalogue Number: 915002-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2014
• 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, SN:UNK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR