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	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Needle did not test appropriately--did not make sound on test fire.Patient on table prepared for stereotactic biopsy.Faulty needle--test did not work properly.Continue to always test the needle before using on patient, none.

• Brand Name: EVIVA_0910-12T
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlborough MA 01752
• MDR Report Key: 23509332
• Report Number: 23509332
• Device Sequence Number: 13207928
• 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): 10/21/2025
• Report Date (Section F): 10/21/2025

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: E25A23RY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 11/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2025
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Date Report Sent to FDA: 10/21/2025