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

Model Number	NS2007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bowel Burn (1756); Uterine Perforation (2121); Burn, Thermal (2530)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that prior to the ablation, the cavity was visualized with no abnormalities noted.The ablation was completed successfully, and a hysteroscopy was again done, with excellent visualization of the fundus and no evidence of perforation.Postoperatively, she did well until day two.The patient developed sudden onset lower abdominal pain and went to er.She was eventually taken to the operating room where a laparoscopy was performed.At this point, there were bowel contents in the abdomen.General surgery was called and an open laparotomy was done, noting two perforations in the ileum.The uterus had two localized and circular cautery marks on the fundus.The patient had a bowel resection.No additional details available at this time.

• Brand Name: NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
• Common Device Name: UTERINE ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, ma
• MDR Report Key: 10401514
• Report Number: 1222780-2020-00108
• Device Sequence Number: 16878473
• Product Code: MNB
• UDI-Device Identifier: 35420045501137
• UDI-Public: (01)35420045501137(10)20B18RD
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: NS2007
• Device Catalogue Number: NS2007
• Device Lot Number: 20B18RD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RADIO FREQUENCY CONTROLLER, SN (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention