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

Model Number NSV5KITUS-001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/05/2024

Event Type  Injury  

Manufacturer Narrative

H3: 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.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.Customer reported that they could not differentiate between 2 lot numbers.23h01rf: expiration date : manufacturing date: 08/01/2023.Udi : (b)(4).A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.23k05rs: expiration date : 01/24/2025.Manufacturing date: 05/10/2023.Udi : (b)(4).A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

Event Description

It was reported that on (b)(6) after a novasure procedure was performed on a patient, the patient returned to the doctor¿s office after surgery with pain and difficulty urinating.A ¨plastic cone¨ par from the novasure was removed from her vagina.The patient did not require any additional medication after the device was removed.No other information is available.

• Brand Name: NOVASURE
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 18699341
• MDR Text Key: 335296531
• Report Number: 1222780-2024-00061
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NSV5KITUS-001
• Device Catalogue Number: NSV5KITUS-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other