MAUDE Adverse Event Report: HOLOGIC, INC. BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY; BIOPSY INSTRUMENT

Model Number BREV09

Device Problem Failure to Cut (2587)

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

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.

Event Description

It was reported that the equipment and needle were set up and tested correctly.After taking 6 tissue samples there were no calcifications visible.After taking 18 tissue samples, only 8 very small samples were available.It was unknown if the samples would be sufficient for diagnosis.Additional information obtained from the customer confirmed that the patient will need to undergo another biopsy due to insufficient tissue sampling.

• Brand Name: BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 11591287
• MDR Text Key: 243111235
• Report Number: 1222780-2021-00066
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045507777
• UDI-Public: 15420045507777
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2021
• Device Model Number: BREV09
• Device Catalogue Number: BREV09
• Device Lot Number: 10151249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other