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

Model Number V5

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

Patient Problem Uterine Perforation (2121)

Event Date 04/03/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that on (b)(6) 2023, during a novasure procedure, the physician could not pass cia, at one point the patient began to spasm while the device was inside.The patient was stabilized, and another device was attempted to be used but the cia could not pass.The physician decided to abort the procedure on the suspicion of a possible uterine perforation.No other information is available.

• Brand Name: NOVASURE
• 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: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 16787044
• MDR Text Key: 313741506
• Report Number: 1222780-2023-00134
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045514300
• UDI-Public: (01)15420045514300(17)241224(10)22M05RL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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: 22M05RL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other