MAUDE Adverse Event Report: HOLOGIC, INC. EVIVA_0913-20; INSTRUMENT, BIOPSY

Model Number	EVIVA_0913-20
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that during a breast biopsy on (b)(6) 2026 with an eviva device that a patient required additional surgical and medical intervention.The report states the "patient had to stay on table for an extended amount of time with 3 sites in the breast cut, to get small sample.Pt had extra imaging done as well".The procedure was able to be completed with the same device.The reporter states there was patient harm in that they required 3 biopsy sites, and additional imaging.

• Brand Name: EVIVA_0913-20
• Common Device Name: 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: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 25443634
• Report Number: 1222780-2026-00357
• Device Sequence Number: 12194368
• Product Code: KNW
• UDI-Device Identifier: 15420045504974
• UDI-Public: (01)15420045504974(17)280409(10)E26D10RC
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: EVIVA_0913-20
• Device Catalogue Number: EVIVA_0913-20
• Device Lot Number: E26D10RC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown