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

Model Number	NS2007US
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
The device would not clamp or lock.The vendor said that the device was defective.The operating room rn got another device.The second device worked perfectly.The procedure was completed.

• Brand Name: NOVASURE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC; marlborough MA 01752
• MDR Report Key: 7048374
• Report Number: MW5073441
• Device Sequence Number: 13815627
• Product Code: MNB
• UDI-Device Identifier: 25420045501130
• UDI-Public: (01)25420045501130(10)17F28RH
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: NS2007US
• Device Lot Number: 17F28RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1