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

Model Number	EVIVA 0913-12T
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was conducted: investigation methods and findings: visual and functional analysis/testing according to eviva disposable device post market instructions could not be conducted for the described event due to the device not being available for return.Cause/root cause: 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 root cause analysis did not identify a definitive cause.A thorough review of device history records, complaint data, risk assessments, and testing did not reveal a specific failure mode.The risk trending calculations results do not increase the risk index zone.No further actions are required at this moment.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: the dhr review was conducted for this eviva disposable finish good lot and no non-conformances or deviations were found.
Event or Problem Description
It was reported that an eviva breast biopsy procedure was completed on a patient on (b)(6) 2026.The user reports that samples of breast tissue were collected; however, when removing the device prior to inserting the marker, the "techs had a difficult time." it is further reported that the "end of the sheath was crumpled and looked damaged." there was no reported patient harm, and the procedure was successfully completed with the same device.No further information is currently available.

• 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: 24649263
• Report Number: 1222780-2026-00131
• Device Sequence Number: 18588568
• Product Code: KNW
• UDI-Device Identifier: 15420045505339
• UDI-Public: (01)15420045505339(17)260709(10)E24G09RG
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 05/14/2026

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 Expiration Date: 07/09/2026
• Device Model Number: EVIVA 0913-12T
• Device Catalogue Number: EVIVA 0913-12T
• Device Lot Number: E24G09RG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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