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

Model Number	NOVASURE CONTROLLER
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.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.3 affected items were used in this event that were reported to the fda under : 1222780-2021-00126 : novasure rf controller model 10, 1222780-2021-00127 : novasure suresound 2007, 1222780-2021-00128 : novasure suresound 2007.
Event or Problem Description
It was reported that during a novasure procedure the device started getting hot for a few seconds prior to the ablation.No injury to the patient or user was reported.Another novasure was used and after the procedure a hole in the array was observed.No more information is available.
Additional Manufacturer Narrative
The novasure rfc system was evaluated by manufacturing operations on (b)(6) 2021.The rfc unit was returned due to a potential issue, described by the end user as the rf power output enabling spontaneously when the disposable hand piece is installed.A visual inspection was completed; there were no obvious signs of damage or misuse observed.The rfc device was subjected to functional testing and passed all final inspection tests and high pot electrical safety testing.There was no fault observed on the returned system.The reported complaint has been not confirmed at this time, it is not possible to identify the root cause of the reported complaint.Hologic has previously found system fault 002 failures to be related to a memory corruption issue in the software.The device history record was reviewed for this serial number, the device was released meeting all inspection criteria.Hologic will continue to track and trend this failure mode.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.

• Brand Name: NOVASURE
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 11962625
• Report Number: 1222780-2021-00126
• Device Sequence Number: 19895309
• Product Code: MNB
• UDI-Device Identifier: 15420045500860
• UDI-Public: (01)15420045500860(11)171216
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Followup
• Report Date (Section B): 06/23/2021

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 Model Number: NOVASURE CONTROLLER
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOVASURE SURESOUND NS2007; NOVASURE SURESOUND NS2007
• Outcome Attributed to Adverse Event: Other