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

Model Number	NS2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Standard dhr review|a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications (b)(4).
Event or Problem Description
It was reported that an uncomplicated novasure endometrial ablation was performed by a physician on (b)(6) 2018.The next day the patient was "admitted and underwent surgery including a bowel resection".No additional information was received.
Event or Problem Description
"the patient called 24 hours later with rigors that spontaneously resolved.At 36 hours post-procedure, she went to the er with fever.A ct-scan showed abnormal changes in the myometrium along with fluid and free air in the pelvis.She was taken to the or for a laparotomy.Upon entry into the abdomen, bowel contents were noted.A portion of bowel was adherent to the posterior wall of the uterus.The bowel was dissected off of the uterine wall; blanching of the uterine serosa was noted along the posterior fundus consistent with thermal injury.A thermal injury with perforation was identified on the small bowel at the distal ileum.A resection with primary anastomosis was performed.The patient was discharged home in stable condition after one week of hospitalization".
Additional Manufacturer Narrative
The radio frequency controller (rfc) was returned on 06/07/2018: rf controller s/n (b)(4) passed all functional testing.This observation will be monitored and trended.Standard dhr review|a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.

• Brand Name: NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
• Common Device Name: UTERINE ABLATION DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7593274
• Report Number: 1222780-2018-00127
• Device Sequence Number: 11187201
• Product Code: MNB
• UDI-Device Identifier: 45420045501134
• UDI-Public: 45420045501134
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 02/08/2019
• Device Model Number: NS2000
• Device Catalogue Number: 915002-01
• Device Lot Number: 18A08RK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 06/07/2018; 06/16/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 06/21/2018; 07/19/2018
• 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; Required Intervention