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

Model Number	NS2007US
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Results from investigation : as received from the field, the external sheath was crumpled.This most likely occurred during the array retraction post ablation due to the tissue increasing the external diameter of the array in relationship to the internal diameter of the external sheath.Every novasure disposable device is inspected to ensure proper device deployment and retraction prior to final release.This observation will be monitored and trended.
Event or Problem Description
It was reported that on (b)(6) 2020 after a novasure procedure the device appeared frayed and burned at the end, after receiving the product and inspection on january 12th by investigators, the external sheath was observed as crumpled.No injury to the patient was reported.No other information available.

• 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: 11209630
• Report Number: 1222780-2021-00004
• Device Sequence Number: 3557066
• Product Code: MNB
• UDI-Device Identifier: 15420045501140
• UDI-Public: (01)15420045501140(10)20G30RK(17)220228
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 01/21/2021

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: 02/28/2022
• Device Model Number: NS2007US
• Device Catalogue Number: NS2007US
• Device Lot Number: 20G30RK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1