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

Model Number	BREV200
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional 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 lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.Console was examined and tested : multiple test cutting cycles completed with two separate needles, all cycles completed without error.Motor accuracy tests completed - all found within specification.Error logs checked however unable to see any errors potentially causing issue.The device met the manufacturer´s specifications.2 needles were used in this event, reported under 1222780-2022-00281 and 1222780-2022-00282.
Event or Problem Description
On friday afternoon they had a stereo to do on the brevera.When the nurse went to put the specimen in the path container there was no tissue in the 12-chamber tissue filter.They reset up with all new kit and took another sample, again there was no tissue sample.No error codes or messages are displayed on the unit.The involved needles were cut from their tubing and disposed of.No injury, but the patient has been rescheduled for another biopsy.No additional information is available.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM
• Common Device Name: 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: 15562077
• Report Number: 1222780-2022-00280
• Device Sequence Number: 12199085
• Product Code: KNW
• UDI-Device Identifier: 15420045507753
• UDI-Public: (01)15420045507753(11)181114
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: BREV200
• Device Catalogue Number: BREV200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BREVERA BREAST BIOPSY SYSTEM DISPOSABLE; BREVERA BREAST BIOPSY SYSTEM DISPOSABLE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female