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

Model Number	BREV100
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on july 23, during a biopsy procedure, while the needle was in the breast an imaging system error occurred and the staff was unable to clear with a full shutdown.No sampling was retrieved and the patient will be rescheduled.A field engineer examined the unit and found the error that was described, the field engineer removed covers and reseated all corlumina connections, booted the system, and completed start-up tests.No further errors were found.The field engineer verified repair fixed the reported issue.The system meets manufacturer specifications on july 23.No additional information available.
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.
Additional Manufacturer Narrative
It was reported that on (b)(6) -2024 the customer experienced a csl an imaging system error while the brevera biopsy needle was in the patient¿s breast but not fired.No samples were retrieved, and no backup biopsy device was available; therefore, the procedure was aborted, and the patient was rescheduled.A hologic field service engineer (fse) visited the site and confirmed the issue.The brevera system covers were removed and all of the corlumina connections were reseated.The system was then powered back up and start up tests were completed with no further errors.It was verified that the repair fixed the reported issue, and the system was released back to the customer.The device was not returned for investigation as the corlumina was not replaced and was left in the customer¿s possession.According to the brevera system history, this is the original corlumina for this system and had been in use for 2261 days at the time of the reported complaint.The device corlumina was not replaced; therefore, no product was returned for further investigation.Conclusion: the cause of the imaging system error was unable to be established.No product was returned for evaluation as the work performed by the hologic fse at the customer site was able to resolve the issue.Based on the fact that reseating the corlumina connections and rebooting the system resolved the reported issue, one could assume that a loose connection was the likely culprit for the error code experienced by the customer.Loose connections could arise from vibrations associated with intrahospital transportation or repeated movement of the system.Future occurrences of similarly reported events will continue to be monitored and trended.Complaint confirmed: no ¿ no product returned for further investigation.Device history record (dhr) review: the device history record for the serial number involved was reviewed and was found to have met all manufacturing requirements prior to shipment for distribution.This includes final inspection and packaging inspection.The device history record for the orion was reviewed and was found to have met all manufacturing requirements prior to shipment for distribution.This includes final inspection, in-process checklist/inspection, and the functional test inspection record.No discrepancies were listed, and all phases/operations were marked as ¿passed¿.Date of manufacture: 11-apr-2018 (whole system); 01-mar-2019 (orion).Date of installation: (b)(6) 2018 (whole system, including orion).Date of last pm: suggested date (b)(6)2024, performed (b)(6)2024.System serial number: (b)(6) unique device identifier (udi) information: (b)(4).

• Brand Name: BREVERA 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, MA 20102
• MDR Report Key: 19932870
• Report Number: 1222780-2024-00254
• Device Sequence Number: 2846541
• Product Code: KNW
• UDI-Device Identifier: 15420045507517
• UDI-Public: (01)15420045507517(11)180411
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BREV100
• Device Catalogue Number: BREV100
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female