AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
Received Jul 21, 2026 · Event occurred Jun 26, 2026
Report 3005496266-2026-00196 · MDR key 25896163
Device
Generic name
System, X-ray, Mammographic
Manufacturer
Hologic, Inc.Model number
STLC-00004Catalog number
STLC-00004
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE USER THAT DURING A PATIENT PROCEDURE ON (B)(6) 2026, USING THE AFFIRM UPRIGHT BREAST BIOPSY GUIDANCE SYSTEM, "IT DID NOT TARGET CORRECTLY." IT WAS FURTHER REPORTED THAT THE BIOPSY PROCEDURE WAS SUCCESSFULLY COMPLETED; HOWEVER, AN ADDITIONAL SKIN INCISION TO THE PATIENT WAS REQUIRED TO DO SO. A REMOTE APPLICATIONS INVESTIGATION WAS HELD WITH THE USER AND A HOLOGIC APPLICATION SUPPORT SPECIALIST. IT WAS FOUND THAT THE NEEDLE DATA WAS CORRECT AND UPON REVIEW OF THE BIOPSY CASE, "THE NEEDLE APPEARED TO BE ON TRACK WITH WHERE THE TARGET WAS PROJECTED." FURTHER, THE APPLICATION SPECIALIST WAS UNABLE TO FIND ISSUE WITH THE DEVICE. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.