MAUDE Adverse Event Report: HOLOGIC, INC EVIVA 0913-12T; INSTRUMENT, BIOPSY

Model Number	EVIVA 0913-12T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was conducted: the device was not available for return; visual and functional analysis/testing could not be conducted for the described event.The device was not returned for this complaint, and only limited patient-related information was provided.Therefore, a full investigation could not be conducted.Without the returned device, it is not possible to confirm a definitive root cause of the issue.Root cause analysis did not identify a definitive root cause.The investigation included a comprehensive review of complaint data and risk assessments, but could not perform any testing procedures, because the device was not returned.Conclusion: the reported issue could not be confirmed because the device was not returned.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.Capa/hra/ncr/scar are not deemed required at this moment by this event.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: the dhr was reviewed for the corresponding lot, and no relevant risk factors were found in the manufacturing process.
Event or Problem Description
It was reported that during an eviva breast biopsy procedure on (b)(6) 2026, "the adapter to the hand piece was defective and the biopsy marker was not able to be placed through it." it was reported that the user was able to successfully complete the biopsy procedure and marker placement by opening and using another device.No patient/user harm was reported.

• Brand Name: EVIVA 0913-12T
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 24456362
• Report Number: 1222780-2026-00084
• Device Sequence Number: 15954316
• Product Code: KNW
• UDI-Device Identifier: 15420045505339
• UDI-Public: (01)15420045505339(17)271001(10)E25K01R
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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 0913-12T
• Device Catalogue Number: EVIVA 0913-12T
• Device Lot Number: E25K01R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown