FDA Adverse Event Injury Summary report: N

HOLOGIC EVIVA PROBE

MDR report key: 23977637 · Received January 6, 2026

Report

Report Number
MW5181834
Event Type
Injury
Date Received
January 6, 2026
Date of Event
November 26, 2025
Report Date
December 29, 2025
Manufacturer
HOLOGIC, INC.
Product Code
KNW
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

DURING A MAMMOGRAPHY BIOPSY PROCEDURE USING A EVIVA NEEDLE, THE PERFORMING PHYSICIAN WAS TAKING SAMPLES, BUT NOT ENOUGH TISSUE WAS BEING TAKEN OUT. THE PHYSICIAN WENT TO TAKE MORE SAMPLES BUT NOT MUCH WAS BEING TAKEN OUT. THE PHYSICIAN ASKED THE MAMMOGRAPHY STAFF TO SET UP A NEW NEEDLE, DURING THE SET UP AND TESTING ON THE NEW NEEDLE, THE NEEDLE WAS NOT PERFORMING AS IT NORMALLY DOES BY TESTING THE SUCTION. IN ATTEMPTS TO TROUBLESHOOT THE PROBLEM THE MAMMOGRAPHY STAFF GOT ANOTHER MACHINE AND SET UP THE SECOND NEEDLE AND AGAIN WAS NOT PERFORMING AS IT NORMALLY DOES. AFTER THE SECOND NEEDLE DID NOT WORK THE MAMMOGRAPHY STAFF OPENED A THIRD NEEDLE AND BEGAN TO SET UP AND TEST THAT NEEDLE. EVERYTHING WITH THE THIRD NEEDLE WENT NORMALLY WITH THE SET UP, TESTING AS WELL AS THE BIOPSY. WE WERE ABLE TO GET MORE OF A TISSUE SAMPLE FROM THE PATIENT. <BR/>AFTER THE BIOPSY WAS DONE WE PUT IN A TITANIUM MARKER TO MARK THE SITE OF THE BIOPSY. DURING THE DRESSING OF THE PATIENT BIOPSY SITE THE MARKER FELL OUT. THE PERFORMING PHYSICIAN DID NOT PUT IN A SECOND MARKER DUE TO THE PATIENT HAVING OTHER LANDMARKS TO DETERMINE THE SITE OF THE BIOPSY. WHEN THE PATIENT LEFT THE PERFORMING PHYSICIAN NOTICED THAT THE WRONG BIOPSY SITE MARKER WAS USED AND THAT IT WAS AN ULTRASOUND T3 SITE MARKER INSTEAD OF A STEREOTACTIC T3 SITE MARKER. THE PATIENT DID NOT NEED ANY FURTHER TESTING. PT CODE: 4582. DEVICE CODE: 2170. REF REPORT: MW5181833.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
47831 HOLOGIC EVIVA PROBE INSTRUMENT, BIOPSY KNW HOLOGIC, INC. EVIVA_0913-20 E25H16R/E25H22RF

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Required Intervention