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

Model Number BREVERA DRIVER

Device Problem Failure to Obtain Sample (2533)

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

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

Event Description

It was reported that during a brevera biopsy on (b)(6) 2024 , a driver error was observed and the procedure could not be completed.The needle was inside the breast and an incision had been made.A field engineer spoke with the customer and it was determined that the customer had performed an incorrect selection on the console.No other information is available.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; san jose 20102 ; CR 20102
• MDR Report Key: 19201430
• MDR Text Key: 341263086
• Report Number: 1222780-2024-00161
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045507760
• UDI-Public: (01)15420045507760(11)210401
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BREVERA DRIVER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other