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

Model Number	2007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Bowel Burn (1756); Uterine Perforation (2121)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Additional 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.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 event: 1222780-2024-00011.
Event or Problem Description
It was reported that on (b)(6) a novasure procedure was performed and after 22 seconds of ablation, a check array error was received.The doctor removed the array from the patient to check the array and did not see any obvious damage to the array.The device was checked before the procedure and no malfunction was observed.The doctor reseated the device and restarted the ablation.The ablation continued for another 4 seconds before receiving another check array error.The doctor chose to open a second device.A novasure classic device was opened to continue the procedure.The array was checked prior to deploying in the cavity with no damage observed.The cavity assessment failed and the doctor attempted to improve the cervical seal and failed again.The doctor removed the device to perform a repeat hysteroscopy and discovered a perforation.The procedure was aborted after the perforation was observed and laparoscopy was performed to confirm that there was no damage to the surrounding area due to the perforation or ablation from the first device.After the procedure, the patient was presented to the emergency room with chest and abdominal pain.The patient had ct scanning and various other tests.The physician performed a bowel resection to the patient.Also, there was a thermal injury to the bowel.The patient is currently still at the hospital recovering.No sepsis was noted.No additional information available.

• Brand Name: NOVASURE STERILIZED AND SURESOUND
• Common Device Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough 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: 18468658
• Report Number: 1222780-2024-00010
• Device Sequence Number: 17909079
• Product Code: MNB
• UDI-Device Identifier: 15420045501140
• UDI-Public: (01)15420045501140(17)250510(10)22K18RB
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2024
• Device Model Number: 2007
• Device Catalogue Number: NS2007US
• Device Lot Number: 22K18RB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Female