MAUDE Adverse Event Report: HOLOGIC, INC IMPED CONTR ENDOM ABLATION DISP NOVASURE; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number	NS2000US
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) performing novasure ablation.Ablation would not complete cycle.Several attempts were made to correct the error messages that kept occurring on the generator.A second novasure device was opened and used and completed the cycle without incident.Fda safety report id # (b)(4).

• Brand Name: IMPED CONTR ENDOM ABLATION DISP NOVASURE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC; MA 01752
• MDR Report Key: 12107281
• Report Number: MW5102246
• Device Sequence Number: 19827277
• Product Code: MNB
• UDI-Device Identifier: 25420045501147
• UDI-Public: 25420045501147
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: NS2000US
• Device Catalogue Number: NS2000US
• Device Lot Number: 21D13RA
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR