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

Model Number	NS2013US
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The novasure device kit isn't working properly with ref number of ns2013us with lot# of 2460212.

• Brand Name: NOVASURE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlborough MA 01752
• MDR Report Key: 20771068
• Report Number: 20771068
• Device Sequence Number: 18177028
• Product Code: MNB
• UDI-Device Identifier: 25420045501116
• UDI-Public: (01)25420045501116
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/01/2024
• Report Date (Section F): 11/01/2024

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 Model Number: NS2013US
• Device Catalogue Number: NS2013US
• Device Lot Number: 24G02R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 11/01/2024