MAUDE Adverse Event Report: Hologic, Inc. EVIVA_0913-20; INSTRUMENT, BIOPSY

Model Number	EVIVA_0913-20
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported there was a long cutting time during the last (6th) sample.It was reported that during lavage to collect the samples, there was some minor resistance on rotating the needle to collect samples.The patient reportedly felt an increased pressure in her breast which she said was tolerable, but not painful.Upon imaging the sample, only a few microcalcifications were seen.The customer reported as the patient "felt fine," additional samples were taken.3 more samples were taken with the same reported resistance when turning the notch as the initial samples.As the patient reportedly felt an increased pressure in her breast again but no pain, the needle was withdrawn.The tip of the needle was then observed to be bent.The consultant radiologist withdrew the needle from the breast carefully.The needle was stuck to the introducer as it was bent and could not be withdrawn through the introducer.The needle and introducer were removed as a unit from the patient.A new needle pack was opened to get another plastic introducer sheath in order to insert a marker clip, and ended the procedure.The was no report of patient or user harm.No further information is available at this time.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.

• Brand Name: EVIVA_0913-20
• 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: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 50045708
• Report Number: 1222780-2026-00462
• Device Sequence Number: 15818074
• Product Code: KNW
• UDI-Device Identifier: 15420045504974
• UDI-Public: (01)15420045504974(17)280206(10)E26B06RQ
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/27/2026

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: E26B06RQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2026
• 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