MAUDE Adverse Event Report: HOLOGIC, INC. NOVASURE SURESOUND; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number	2007
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
While using a novasure device, the surgeon couldn't pass the cavity assessment.If you do not pass the cavity assessment, you cannot perform the procedure.A seal within the cervix must be maintained for it to pass the cavity assessment.Per surgeon, there was no concern for cervix being patulous nor for perforation.The rep was called and placed on speaker.She guided the surgeon through the same steps she had performed prior twice.The rep told the surgeon to obtain a new device as the initial one could be faulty.The surgical team obtained a second device and the procedure was completed successfully with no harm to the patient.The device and packaging were saved and will be returned to the manufacturer by clinical engineering.Per site reporter: the representative was made aware during surgery, aided in troubleshooting, and ultimately suggested using a new device.We will coordinate with the rep to return the device to hologic quality team.

• Brand Name: NOVASURE SURESOUND
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7040432
• Report Number: 7040432
• Device Sequence Number: 11238135
• Product Code: MNB
• UDI-Device Identifier: 25420045501130
• UDI-Public: (01)25420045501130
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2017
• Report Date (Section F): 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/02/2018
• Device Model Number: 2007
• Device Catalogue Number: NS2007US
• Device Lot Number: 17C02RA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 68
• Date Report Sent to FDA: 11/06/2017