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

Model Number BREVDISP09

Device Problem Failure to Obtain Sample (2533)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6), a brevera procedure was performed and during the procedure after the needle was inserted into the breast, the needle made an odd sound when firing, and then got a system error.The doctor removed the needle from the patient and connected a new needle, the same issue occurred when firing.The doctor rebooted the system and attempted to test the fire needle, getting the same error and sound.The patient was rescheduled for a new procedure.No additional information available.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM DISPOSABLE
• Type of Device: INSTRUMENT, BIOPSY
• 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: 18616905
• MDR Text Key: 334230103
• Report Number: 1222780-2024-00031
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: (01)15420045512863(17)251011(10)23K12RD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2024

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
• Device Operator: Health Professional
• Device Model Number: BREVDISP09
• Device Catalogue Number: BREVDISP09
• Device Lot Number: 23K12RD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female