MAUDE Adverse Event Report: HOLOGIC, INC NOVASURE V5; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number V5

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 07/27/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6), a novasure procedure was performed, and post-procedure the patient was complaining of vaginal discomfort.It was discovered that the cervical seal had remained in the patient post-ablation.The staff did not notice at the time of procedure completion, that the cervical seal did not come out with the novasure device.The cervical seal was removed, but the date was not provided.No additional information available.

Manufacturer Narrative

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.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 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.

• Brand Name: NOVASURE V5
• 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 18318330
• MDR Text Key: 330380844
• Report Number: 1222780-2023-00461
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: V5
• Device Catalogue Number: NSV5KITUS-001
• Device Lot Number: 23C06RK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female