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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.The device was returned for evaluation and a visual inspection was conducted.The cervical seal was detached from the device.Functional testing was not conducted because the damage was confirmed in the visual inspection and the device cannot be tested due to the damage.Hence, the complaint can be confirmed.This observation will be monitored and trended.

Event Description

It was reported that on january 24th, a novasure procedure was performed and the device had trouble passing the cavity assessment test.The doctor performed troubleshooting steps and removed the device to expand the array as part of her check.The array opened without issue, but when they looked at the device the tip of the collar was missing.They found it in the cervix.No additional information available.

• 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 ; CR 20102
• MDR Report Key: 18793305
• MDR Text Key: 336960081
• Report Number: 1222780-2024-00076
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 23K17RC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female