MAUDE Adverse Event Report: HOLOGIC, INC NOVASURE V5; DEVICE, THERMAL ABLATION, ENDOMETRIAL

Model Number V5

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

Patient Problem Bowel Burn (1756)

Event Date 04/20/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6), a novasure procedure was performed and a first device was used but they kept getting vacuum alarms and the width dial was filling up with blood.They used a second novasure device where the procedure went as normal, with no issues.The doctor scoped the patient after the procedure and the ablation looked good.Two days after the procedure on (b)(6) 2023 the patient went to the hospital complaining of pain where a laparoscopic diagnostic was done.It was confirmed that had a bowel injury.They said it looked like it burned through the wall and not a hole.The patient was taken to surgery and is still in the hospital.No additional information available.

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.D4: lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.H3: 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.2 devices were involved in this case: 1222780-2023-00153.

• Brand Name: NOVASURE V5
• 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: 16864810
• MDR Text Key: 314508456
• Report Number: 1222780-2023-00152
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: No
• 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