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

Model Number NS2000

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 05/11/2015

Event Type  Injury  

Event Description

It was reported, a physician successfully completed a novasure endometrial ablation on (b)(6) 2015.The physician then performed a post hysteroscopy which demonstrated good results.The dr.Proceeded to perform a scheduled laparoscopic sterilization procedure and observed "left blanching spot on left fundus from the novasure." the bowel was inspected and no injury was found.The pt was discharged the same day.Additional info was received on (b)(6) 2015, reporting there was no evidence of bowel injury.Antibiotics were administered to the pt and reportedly she is doing "ok".

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.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 manufacture 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.(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: 4847731
• MDR Text Key: 22031344
• Report Number: 1222780-2015-00104
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• 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?: Yes
• Date Manufacturer Received: 05/11/2015
• 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): Other
• Patient Age: 35 YR