MAUDE Adverse Event Report: HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L NOVASURE SURESOUND; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number	NS2013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Uterine Perforation (2121)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
Event or Problem Description
I was reported on (b)(6) 2020 that a physician performed a novasure procedure on the patient, prior to the procedure a hysteroscopy was performed and there were no areas of injury.After the procedure physician stated that laparoscopy was performed and a fundal perforation was seen at fundus.No bowel injury was visualized.The perforation was not treated and that there are currently no additional details available about current patient status.
Additional Manufacturer Narrative
The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.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 SURESOUND
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L; 562 parkway; coyol free zone building b24; san josé., alajuela 20102 ; CS 20102
• MDR Report Key: 10823294
• Report Number: 1222780-2020-00148
• Device Sequence Number: 3334527
• Product Code: MNB
• UDI-Device Identifier: 15420045501140
• UDI-Public: (01)15420045501140(10)20G30RK(17)220228
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: NS2013
• Device Catalogue Number: NS2013
• Device Lot Number: 20G30RK
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 04/05/2021
• 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: Other