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

Model Number 2000

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

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.No dhr review performed.A device history record (dhr) review could not be conducted as the lot/serial number was not provided by the complainant.Or the product is non traceable.

Event Description

It was reported that on february 23rd, after a novasure procedure a visual inspection revealed foreign material on the mesh that was not present at the start of the procedure.Physician suspected it might have melted from the array.The physician had to perform a hysteroscopy to check if any debris were left inside the patient.There were no debris inside the uterus.No patient injury was reported.

Manufacturer Narrative

The device reported in cpt-5081980 was received and tested.Upon visual inspection it was confirmed that material was adhered to the outer bottom surface of the mesh of the array.The material was removed and the integrity of the array and external sheath was inspected.However, no observable defects were noted.The material was also analyzed using a microscope and it was determined to be biological tissue that got adhered to the mesh as a result of the ablation procedure.No further functional testing was executed.The reported observation could not be confirmed.This observation will be monitored and trended.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
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 11596593
• MDR Text Key: 256233328
• Report Number: 1222780-2021-00062
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• PMA/PMN Number: P010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2000
• Device Catalogue Number: NS2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other