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	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: biopsy needle did not pass test run when attached correctly.Would not "fire".Needle info: eviva stereotactic guided breast biopsy system biopsy device: petite size, lot e25j29rj, exp 9/29/2027.

• Brand Name: EVIVA_0910-12T
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 24895095
• Report Number: 24895095
• Device Sequence Number: 10493782
• 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): 04/07/2026
• Report Date (Section F): 04/07/2026

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: E25J29RJ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Date Report Sent to FDA: 04/07/2026