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

Model Number	EVIVA 0913-12T
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was conducted: it was reported that at the conclusion of an eviva breast biopsy procedure on (b)(6) 2026, the user attempted to remove the device from the patient's breast; however, "the needle got stuck." it is reported that the user had to remove both the introducer and needle together in order to remove the needle from the breast.The user further reports that once the introducer was removed, it appeared "bent/squished." no patient harm was reported, and the procedure was successfully completed with the same device.Initial evaluation: the device was not available for return; visual and functional analysis/testing could not be conducted for the event described.Investigation methods and findings: the device was not returned for this complaint.Therefore, a full investigation could not be conducted.However, an image provided by the customer reflects the protective sheath bent.Cause/root cause: the investigation included a comprehensive review of device history records, complaint data, risk assessment, and testing results, finding the most probable cause to be the protective sheath being bent.Conclusion: 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 of this report do not increase the risk index zone.No further action is required at this moment.Future events will be monitored and trended.Complaint confirmed: yes.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 at the conclusion of an eviva breast biopsy procedure on (b)(6) 2026, the user attempted to remove the device from the patient's breast; however, "the needle got stuck." it is reported that the user had to remove both the introducer and needle together in order to remove the needle from the breast.The user further reports that once the introducer was removed, it appeared "bent/squished." no patient harm was reported, 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: 24462255
• Report Number: 1222780-2026-00093
• Device Sequence Number: 13105478
• Product Code: KNW
• UDI-Device Identifier: 15420045505339
• UDI-Public: (01)15420045505339(17)271202(10)E25M02R
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: E25M02R
• 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: 12/02/2025
• 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