MAUDE Adverse Event Report: HOLOGIC, INC. EVIVA_0910-12T; INSTRUMENT, BIOPSY

Model Number	EVIVA_0910-12T
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: the stereotactic breast biopsy device did not pass the initial set-up check.After the breast biopsy device was attached to biopsy machine and set-up as stated by manufacture guidelines a test fire was done.The biopsy device did not pass test fire stage.This device was removed from the area, and a new biopsy device was opened.The biopsy device did not come in contact with the patient.Eviva stereotactic guided breast biopsy petite system.Lot-e25g02rj, exp 2027-07-02.

• Brand Name: EVIVA_0910-12T
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlborough MA 01752
• MDR Report Key: 24290722
• Report Number: 24290722
• Device Sequence Number: 9435805
• Product Code: KNW
• UDI-Device Identifier: 15420045504943
• UDI-Public: (01)15420045504943
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026
• Report Date (Section F): 02/04/2026

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
• Operator of Device: Health Professional
• Device Model Number: EVIVA_0910-12T
• Device Catalogue Number: EVIVA_0910-12T
• Device Lot Number: E25G02RJ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Date Report Sent to FDA: 02/04/2026