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

Model Number	EVIVA_0913-20
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: while setting up the eviva stereotactic guided breast biopsy system the needle did not pass the set-up stage on the first try.Then during the test stage of set-up, the biopsy window did not open and close appropriately.At that time the biopsy device was disconnect form the pearl machine and a new stereotactic guided breast biopsy system was opened and set-up for the procedure.The manufacturer is investigating as this has been an issue with multiple devices.Manufacturer response for instrument, biopsy, eviva_0913-20 (per site reporter).Investigating as this has been an issue with multiple devices.

• Brand Name: EVIVA_0913-20
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 25347559
• Report Number: 25347559
• Device Sequence Number: 10310955
• 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: E26A26RF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 3 KG
• Date Report Sent to FDA: 05/22/2026