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

Model Number 2013

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vesicovaginal Fistula (4512)

Event Date 03/02/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, it was reported that a patient, who had a history of two previous caesarian sections, underwent a novasure ablation procedure in (b)(6) 2023.One week after the procedure, the patient developed mictional complaints.She was treated for a urinary tract infection two weeks after surgery.One month after the procedure, she had involuntary urine leakage.Six weeks after the procedure, a fistula between the bladder and the uterus (transition corpus-cervix) was diagnosed in the patient.According to the physician, ¿the procedure was carried out in the usual manner.The patient is scheduled for surgical correction at the end of march.The patient is physically healthy.Due to psychological problems, she uses psychopharmaceuticals.".

Manufacturer Narrative

Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.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.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 STERILIZED AND SURESOUND
• 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: 16570173
• MDR Text Key: 311561319
• Report Number: 1222780-2023-00079
• Device Sequence Number: 1
• Product Code: MNB
• UDI-Device Identifier: 15420045508224
• UDI-Public: (01)15420045508224(17)240917(10)22H29RB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2013
• Device Catalogue Number: NS2013KITUS
• Device Lot Number: 22H29RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2022
• 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 Outcome(s): Other; Required Intervention