MAUDE Adverse Event Report: HOLOGIC, INC EVIVA_1213-20; INSTRUMENT, BIOPSY

Model Number	EVIVA_1213-20
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an eviva procedure on (b)(6) 2025, "needle tip twisted at notch on tissue sampling.Initial sampling successful with some specimen.Second round sampling produced no tissue sample and when we wound the needle out of the patient breast, we noticed the needle tip had twisted." it is reported that the procedure was successfully completed with another device.No patient/user injury was reported, and no further information is currently available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

• Brand Name: EVIVA_1213-20
• 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: 23767918
• Report Number: 1222780-2025-00626
• Device Sequence Number: 10594406
• Product Code: KNW
• UDI-Device Identifier: 15420045504998
• UDI-Public: (01)15420045504998(17)261029(10)E24K29RG
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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_1213-20
• Device Catalogue Number: EVIVA_1213-20
• Device Lot Number: E24K29RG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2024
• 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