MAUDE Adverse Event Report: HOLOGIC, INC BREVERA BREAST BIOPSY SYSTEM

Model Number	BREV200
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a brevera biopsy procedure on (b)(6) 2022.The brevera console and the disposable were all successfully tested.The needle was then inserted into the patient breast at the target, but an error message (device driver loss communication) was displayed on the console; therefore the biopsy would not start.The needle was removed, the unit was rebooted but this could not solve the issue.The procedure with brevera system was then abandoned.The medical team decided to use another method: the patient was removed from compression, repositioned and a new target acquired; a second incision was made and the biopsy was completed using another biopsy device.No patient injury (other than a second incision made) or any adverse event was reported related to this incident.The involved brevera needle will not be returned for evaluation, as it was discarded.
Additional 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.A field engineer (fe) visited the site to check the equipment and the reported console malfunction was confirmed.Fe found the error was coming from the driver, which had to be re-initialized.The driver is part of the machine that holds the needle for the biopsy.Once completed all the initialization steps, he simulated the driver firing and a biopsy procedure, which were all successfully completed.Fe confirmed that the root cause was the driver software which had to be re-initialized.The driver part itself did not require to be replaced.The system is working as intended.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM
• Common Device Name: BIOPSY SYSTEM
• 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 ; CR 20102
• MDR Report Key: 15555927
• Report Number: 1222780-2022-00279
• Device Sequence Number: 5684788
• Product Code: KNW
• UDI-Device Identifier: 15420045507753
• UDI-Public: (01)15420045507753(11)181004
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BREV200
• Device Catalogue Number: BREV200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BREVDISP09
• Patient Sex: Female