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

Model Number NS2013KITUS

Device Problems Crack (1135); Failure to Seal (4070)

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

Event Date 06/09/2023

Event Type  malfunction  

Event Description

Provider was handed the novasure device.After putting it into the uterus, the provider noted a crack in the plastic that resulted in the device not being able to seal.

• Brand Name: NOVASURE SURESOUND
• Type of Device: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 17216585
• MDR Text Key: 318027208
• Report Number: 17216585
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NS2013KITUS
• Device Catalogue Number: NS2013KITUS
• Device Lot Number: 23C01RM
• 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: 06/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White