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

Model Number V5

Device Problem Crack (1135)

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

Event Date 06/09/2023

Event Type  malfunction  

Event Description

There was a crack in the product novasure.

• Brand Name: NOVASURE
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marborough MA 01752
• MDR Report Key: 17265776
• MDR Text Key: 318457941
• Report Number: 17265776
• Device Sequence Number: 1
• Product Code: MNB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V5
• Device Catalogue Number: NSV5US-001
• Device Lot Number: 23A12R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA
• Patient Sex: Female
• Patient Weight: 145 KG
• Patient Race: White