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

Model Number BREV100

Device Problem Failure to Obtain Sample (2533)

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

Event Date 06/08/2023

Event Type  malfunction  

Event Description

It was reported that during a brevera biopsy procedure on (b)(6) 2023, in the middle of the biopsy, they were not able to take two specimens and they could not continued.A field engineer examined the equipment and found that the issue could have damaged the internal components of driver.It was found that the driver latch shifted and cause a problem.The driver was replaced and the system was calibrated.The system met the manufacturer´s specifications.No injury to the patient reported.

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.A field engineer examined the equipment and found that the issue could have damaged the internal components of driver.It was found that the driver latch shifted and cause a problem.The driver was replaced and the system was calibrated.The system met the manufacturer´s specifications.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM
• 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: daniel guevara ; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 17257592
• MDR Text Key: 318771326
• Report Number: 1222780-2023-00229
• Device Sequence Number: 1
• Product Code: KNW
• 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: 07/04/2023

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 Operator: Health Professional
• Device Model Number: BREV100
• Device Catalogue Number: BREV100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BREVDISP09