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

Model Number	EVIVA_0913-20
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: the patient was set-up to have a stereotactic biopsy done of her breast.During the biopsy the eviva breast biopsy needle and atec breast biopsy machine would not function correctly.Biopsy setting appeared to be working but there were no specimens being collected.Trouble shooting occurred- suction function was checked, suction canister was replaced, the saline bag was squeezed to try and move possible specimen pieces through the tubing, the machine was turned off and back on and all parts were checked again while needle was inside patient's breast.After that saline was still not traveling through the tubing.Procedure was ended at this point by the radiologist and an attempt to remove specimens from needles was made and sent to the lab.Manufacturer investigating.Manufacturer response for instrument, biopsy, eviva_0913-20 (per site reporter), investigating.

• Brand Name: EVIVA_0913-20
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr.; marlborough MA 01752
• MDR Report Key: 25347496
• Report Number: 25347496
• Device Sequence Number: 10741920
• Product Code: KNW
• UDI-Device Identifier: 15420045504974
• UDI-Public: (01)15420045504974
• 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): 05/22/2026
• Report Date (Section F): 05/22/2026

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_0913-20
• Device Catalogue Number: EVIVA_0913-20
• Device Lot Number: E26806RW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/01/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2026
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Date Report Sent to FDA: 05/22/2026