MAUDE Adverse Event Report: HOLOGIC, INC BREVERA BREAST BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY

Model Number BREV100

Device Problem No Display/Image (1183)

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

Event Date 09/19/2022

Event Type  malfunction  

Event Description

It was reported that during a procedure on (b)(6) 2022, the system was not letting make any exposures.The procedure had to be aborted and the patient rescheduled.A field engineer examined the equipment and determined that a driver needed to be changed and the foot pedal as well.The system was tested extensively and returned to the owner.No other information is available.

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 serial number.The device was released meeting all qa specifications.Device evaluated by mfr: a field engineer examined the equipment and determined that a driver needed to be changed and the foot pedal.System was investigated and the system is throwing multiple errors during use, when adjusting driver cable position system loses communication with driver.The system was tested extensively and returned to the owner.No other information is available.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY
• Type of Device: 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: 15625938
• MDR Text Key: 302296455
• Report Number: 1222780-2022-00295
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045507517
• UDI-Public: (01)15420045507517(11)180516
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BREV100
• Device Catalogue Number: BREV100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2018
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female