Affirm Breast Biopsy Guidance System STLC-00004Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 15420045505858), received between Feb 23, 2018 and Aug 18, 2026 — classified as 9 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Imprecision” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the user site that during a breast biopsy procedure on (b)(6) 2026, the "targeting is off." It is reported that the procedure was successfully completed; however, an additional skin incision to the patient was required after repositioning. A remote case review with the manufacturer Technical Support was held with the user site. Technical Support found that "the patient was pulling back causing multiple retargets." Additionally, it was determined that the user site was not "nicking the skin prior to entering the needle... this could be why they are not able to get to all green and may be getting 0.1mm on the diff line for X." Technical Support further indicates that the user site provided updated information and confirmed that they have completed additional biopsies after the case review was held and since "using a nick in the skin... the Radiologist has not had any further issue"[s]" with their biopsies."No further information is currently available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50302612 ↗
• InjuryMay 28, 2026Use of Device Problem

  IT WAS REPORTED BY THE USER SITE THAT ON (B)(6) 2026, DURING A BIOPSY PROCEDURE USING THE AFFIRM BREAST BIOPSY GUIDANCE SYSTEM, A NEEDLE STRUCK THE DETECTOR, RESULTING IN A DENT IN THE DETECTOR COVER. THE SITE REPORTED THAT AN INCORRECT NEEDLE TYPE HAD BEEN SELECTED PRIOR TO DEPLOYMENT. WHEN THE NEEDLE WAS FIRED, IT CONTACTED THE DETECTOR PLATFORM, AND THE PATIENT SUSTAINED A SMALL NICK AT THE BOTTOM OF THE BREAST. IT WAS REPORTED THAT THE NEEDLE PASSED THROUGH THE PATIENT¿S BREAST. NO ADDITIONAL MEDICATION OR MEDICAL TREATMENT WAS REQUIRED, AND THE PROCEDURE WAS COMPLETED USING THE SAME NEEDLE. A HOLOGIC FIELD SERVICE ENGINEER (FSE) INSPECTED THE DEVICE AND CONFIRMED THAT THERE WAS NO DAMAGE TO THE DETECTOR. THE FSE REPLACED THE BREAST PLATFORM AND PERFORMED SYSTEM GAIN CALIBRATION AND ARTIFACT EVALUATION. THE NEW BREAST PLATFORM WAS VERIFIED BY THE FSE TO HAVE NO ISSUES. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 25326241 ↗
• InjuryMar 25, 2026Difficult to Advance

  ON (B)(6) 2026, DURING A BREAST BIOPSY PROCEDURE USING THE AFFIRM BREAST BIOPSY GUIDANCE SYSTEM WITH AN EVIVA 0913-20 NEEDLE, UNINTENDED MOVEMENT OF THE Z-AXIS OCCURRED WHEN THE NEEDLE WAS FIRED. THE RADIOLOGIST REPORTED THAT THE NEEDLE WAS ALREADY INSIDE THE PATIENT¿S BREAST IN THE PRE-FIRE POSITION, AND AFTER FIRING, THE NEEDLE ROSE UPWARDS ON ITS OWN DUE TO THIS Z-AXIS MOVEMENT. UPON NOTICING THE UNEXPECTED MOVEMENT, THE RADIOLOGIST CONSIDERED THE TARGETING UNRELIABLE AND STOPPED THE PROCEDURE. THE BIOPSY WAS NOT COMPLETED DURING THIS PROCEDURE AND IS SCHEDULED TO BE REPEATED ON ANOTHER DAY. AS THE PATIENT HAS BEEN RESCHEDULED, AN ADDITIONAL PUNCTURE WILL BE REQUIRED. APART FROM THIS, NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN REPORTED AS A RESULT OF THE UNINTENDED MOVEMENT. THE HOLOGIC TECHNICAL SERVICE TEAM VISITED THE HOSPITAL AND CHECKED THE SYSTEM. FOLLOWING THIS VISIT, THE FIELD SERVICE ENGINEER ADJUSTED THE SYSTEM, AND THE SYSTEM IS NOW EXPECTED TO BE WORKING CORRECTLY. SUBSEQUENTLY, OUR CLINICAL APPLICATION SPECIALIST VISITED THE SITE AT THE RADIOLOGIST¿S REQUEST. A SERIES OF TEST FIRINGS WERE PERFORMED USING A CHICKEN PHANTOM, INCLUDING MULTIPLE FIRINGS, RETARGETING A

  Patient problems: Needle Stick/Puncture

  MAUDE report 24695164 ↗
• MalfunctionMar 19, 2026Positioning Problem

  IT WAS REPORTED BY THE USER SITE THAT DURING AN AFFIRM BREAST BIOPSY GUIDANCE SYSTEM PROCEDURE ON (B)(6) 2026, THAT THE CUSTOMER EXPERIENCED A TARGETING ISSUE IN WHICH THE TARGETED AREA APPEARED TO BE MISALIGNED WITH THE NEEDLE POSITION. IT WAS REPORTED BY THE USER SITE THAT PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS RESCHEDULED TO RETURN FOR THE BIOPSY. NO USER OR PATIENT INJURIES WERE REPORTED. AN APPLICATIONS SPECIALIST CONDUCTED A REMOTE CASE REVIEW WITH THE TECHNOLOGIST AND NOTED THAT THE BREAST THICKNESS WAS 26 MM WHILE A STANDARD NEEDLE WAS USED; A STANDARD NEEDLE IS RECOMMENDED FOR BREAST THICKNESSES OF 28 MM OR GREATER, AND A PETITE NEEDLE IS RECOMMENDED FOR A 26 MM BREAST THICKNESS. DURING THE REVIEW, PENDING TARGETS COULD NOT BE PLACED ON THE STEREO IMAGE PAIR TO DETERMINE THE X, Y, AND Z COORDINATES BECAUSE ONE OF THE STEREO IMAGES INCLUDED PART OF THE PATIENT'S HEAD AND WAS THEREFORE NOT USABLE. THE PHYSICIAN ELECTED NOT TO CONTINUE THE PROCEDURE AND RESCHEDULED THE PATIENT TO RETURN FOR THE BIOPSY, REQUESTING THAT THE SYSTEM BE CHECKED BY SERVICE PRIOR TO THE PATIENT¿S RETURN. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE DEVICE AND PE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646225 ↗
• InjuryJan 15, 2026Positioning Problem

  IT WAS REPORTED BY THE USER SITE THAT ON (B)(6) 2025, DURING AN AFFIRM BREAST BIOPSY GUIDANCE SYSTEM PATIENT EXAM, THE USER DID A TOMOGRAPHY PLACEMENT FOR TARGETING AND WHEN ATTEMPTING TO TAKE ANOTHER PICTURE, THE TARGET WAS OFF. THE USER SITE REPORTED THAT THIS EVENT HAPPENED ON TWO PATIENTS. FOR THE FIRST PATIENT, THE USER SITE REPORTED THAT TWO DIFFERENT POSITIONS WERE USED AS ENTRY SITES. IT WAS REPORTED THAT AFTER STARTING WITH THE FIRST POSITION, THE USER SITE TRIED ANOTHER SUBSEQUENT POSITION DUE TO THE CONTINUATION OF THE TARGETING ISSUES WHILE IN THE FIRST POSITION. THE USER SITE REPORTED THAT THE SAME TARGETING ISSUES WITH THE FIRST PATIENT OCCURRED WITH THE SECOND PATIENT. THE USER SITE REPORTED THAT THE PROCEDURE WAS COMPLETED UTILIZING ANOTHER METHOD OF TARGETING, ORTHOGONAL TARGETING, INSTEAD OF TOMOGRAPHY TARGETING. HOLOGIC TECHNICAL SUPPORT (TS) ASSISTED THE USER SITE BY REVIEWING THE TOMOGRAPHY PLACEMENT. AFTER OBSERVING THE PRE-FIRE IMAGE, HOLOGIC TS CONCLUDED THAT PATIENT MOVEMENT OCCURRED, PULLING BACK APPROX. 1CM, AND OBSERVED THAT THE NEEDLE WAS BENDING. HOLOGIC TS REPORTED THAT THE AFFIRM BREAST BIOPSY GUIDANCE SYSTEM DISPLAYED NORMAL BEHAVIOR, WITH NO FURTHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24084650 ↗
• InjuryOct 7, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED BY THE USER SITE THAT ON (B)(6) 2025, DURING AN AFFIRM BREAST BIOPSY GUIDANCE SYSTEM PROCEDURE THERE WERE TWO STEREOTACTIC BREAST BIOPSIES WHERE THE TARGET SET ON THE WORKSTATION AND WHAT WAS TARGETED AT THE BREAST WAS NOT COORDINATING. THE USER SITE REPORTED THAT THE PROCEDURE WAS COMPLETED FOR ONE PATIENT, AND THE OTHER PATIENT WAS RESCHEDULED TO GO TO ANOTHER FACILITY; HOWEVER, TWO SKIN INCISIONS WERE DONE ON THE PATIENT PRIOR TO RESCHEDULING. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND FOUND A MECHANICAL BEARING FAILURE IN THE Z-AXIS MOVEMENT. THE FSE DETERMINED THAT THE AFFIRM BREAST BIOPSY GUIDANCE SYSTEM NEEDED TO BE REPLACED DUE TO INABILITY TO REPLACE Z-AXIS BEARINGS. THE REPLACEMENT OF THE DEVICE WAS COMPLETED ON SEPTEMBER 30TH, 2025. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23237469 ↗
• InjuryOct 7, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING AN AFFIRM BREAST BIOPSY GUIDANCE SYSTEM PROCEDURE ON (B)(6) 2025, THE USER EXPERIENCED ISSUES OBTAINING CALCIFICATIONS. IT IS REPORTED THAT THE USER VERIFIED THE TARGET BUT COULD NOT GET PROPER CALCIFICATIONS. IT IS REPORTED THAT THE PROCEDURE COULD NOT BE COMPLETED, AND THE PATIENT WILL BE REQUIRED TO RETURN FOR A REPEAT BIOPSY. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND FOUND THAT THE SYSTEM IS INCONSISTENTLY LOSING 0.2-0.3/LBS OF FORCE OVER A PERIOD OF FIVE MINUTES. THE FSE PERFORMED SEVERAL SYSTEM CALIBRATIONS TO RESOLVE THE ISSUE, CONFIRMED THAT THE SYSTEM PASSED QAS AND IS OPERATING AS EXPECTED. THE FSE REPORTS THAT THE SYSTEM MEETS MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23232703 ↗
• InjuryAug 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) A PATIENT WAS LYING DOWN IN THE DECUBITUS POSITION WITH THE AFFIRM STEREO BIOPSY UNIT SET UP IN THE CC POSITION. THE PATIENT WAS IN COMPRESSION WHEN THE TECHNOLOGIST ATTEMPTED TO ADJUST THE TARGET GUIDANCE MONITOR. THE TECH TRIED TO MOVE THE MONITOR SLIGHTLY TOWARDS THE RADIOLOGIST WHEN THE C-CLAMP BECAME DETACHED, CAUSING THE CORNER OF THE MONITOR TO STRIKE THE PATIENT IN THE EYEBROW MAKING A LACERATION. THE PATIENT REQUIRED STITCHES. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 19934116 ↗
• InjuryApr 26, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN AFFIRM PROCEDURE, ON (B)(6) 2024, THE NEEDLE PASSED THROUGH THE PATIENTS BREAST. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND IT WAS DETERMINED THAT THE MAMMOGRAPHERS WERE SELECTING THE EVIVA 9X10X20 FROM THE DROPDOWN BUT USING A 9X13X20 NEEDLE THUS USING THE WRONG SIZE OF NEEDLE. THE NEEDLE PUNCTURED THE OTHER SIDE OF THE BREAST. BANDAGES WERE APPLIED AND NO FURTHER ACTIONS WERE REQUIRED. THE PATIENT WILL BE RESCHEDULED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Skin Tears

  MAUDE report 19197627 ↗
• InjuryJun 29, 2023Device Fell; Device Fell

  IT WAS REPORTED THAT DURING A AFFIRM BREAST BIOPSY GUIDANCE SYSTEM PROCEDURE ON JUNE 2ND , THE Z-AXIS NEEDLE MOVED DOWN BY ITSELF, CAUSING AN UNSPECIFIED BREAST INJURY. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT THE CLUTCH SCREWS GOT LOOSEN, THE CLUTCH SCREWS WERE FIXED AND TESTED AND THE EQUIPMENT MET THE MANUFACTURER´S SPECIFICATIONS. A FOLLOW UP WITH THE CUSTOMER REPORTED THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THAT THE PATIENT WAS RESCHEDULED. NO ADDITIONAL DETAILS COULD BE OBTAINED RELATED TO THE BREAST INJURY, IT IS SUSPECTED THAT IT WAS A SUPERFICIAL CUT BUT COULD NOT BE CONFIRMED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17231487 ↗
• MalfunctionFeb 17, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING A SELENIA DIMENSIONS PROCEDURE DURING A STEREO BIOPSY PROCEDURE THE DEVICE NEEDLE WENT THROUGH THE WHOLE BREAST AND MADE CONTACT WITH THE DETECTOR. A FIELD ENGINEER EXAMINED THE EQUIPMENT AND DETERMINED THAT TARGETING ISSUES WERE FOUND DUE TO CALIBRATION. THE EQUIPMENT WAS CALIBRATED AND TEST AND THE SYSTEM WAS FULLY FUNCTIONAL. NO HARM TO THE PATIENT OR STAFF REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397556 ↗
• MalfunctionOct 29, 2022Imprecision; Failure to Obtain Sample; Imprecision; Failure to Obtain Sample

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN AFFIRM UPRIGHT BIOPSY SYSTEM DURING A NORMAL PROCEDURE , THE SAMPLES COULD NOT RETRIEVE THE CALCIFICATIONS WITH THE COORDINATES PROGRAMMED IN THE MACHINE. THE PROCEDURE WAS ENDED PREMATURELY AND THE PATIENT HAD TO BE RESCHEDULED FOR A NEW PROCEDURE. A FIELD ENGINEER EXAMINED THE CONSOLE AND DETERMINED THAT THE CALIBRATION HAD BEEN DONE CORRECTLY AND ALSO REVEALED SOME INTERNAL COMMUNICATION ERRORS. A MECHANICAL SYSTEM CALIBRATION WAS PERFORMED WHICH REVEALED SOME MOTOR AXIS ERRORS FOUND. THE BIOPSY CONTROL MODULE AND BIOPSY GUIDANCE MODULE WERE REPLACED AND THE SYSTEM MET THE MANUFACTURERS SPECIFICATIONS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695628 ↗
• MalfunctionJan 21, 2020Imprecision; Imprecision

  IT WAS REPORTED THAT THE AFFIRM CRASHED DURING BIOPSY, AFTER RE-TARGETING MORE THAN 1 CM. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THE BCM, BGM PCB, AND BGM CABLE NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9612751 ↗
• MalfunctionAug 13, 2019Imprecision; Imprecision

  IT WAS REPORTED THAT DURING TWO BIOPSY EXAMS THE NEEDLE WENT THROUGH THE PATIENT BREAST AND HIT THE DETECTOR. NO MEDICAL INTERVENTION REQUIRED. IT WAS DETERMINED THAT THE NEEDLE DATA NEEDED TO BE ENTERED AFTER A SOFTWARE UPDATE. AN APPLICATIONS SPECIALIST WAS ABLE TO ASSIST THE CUSTOMER TO ENTER THE NEEDLE DATA. ONCE THIS WAS COMPLETED THE SYSTEM IS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888555 ↗
• MalfunctionJun 18, 2019Imprecision; Imprecision

  IT WAS REPORTED THAT AFTER A SYSTEM UPGRADE AND DURING A BIOPSY PROCEDURE, THE ONLY NEEDLE LISTED WAS THE QAS NEEDLE. THE TECHNOLOGIST SELECTED THE QAS NEEDLE AND ATTEMPTED THE BIOPSY. WHEN THE NEEDLE WAS FIRED, IT HIT THE DETECTOR. NO INJURY REPORTED. CLINICAL APPLICATIONS REMOTELY ENTERED THE SYSTEM AND ENABLED THE CUSTOMER'S NEEDLE SELECTIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8708010 ↗
• MalfunctionMay 10, 2019Imprecision; Imprecision

  IT WAS REPORTED THAT A SUPERFICIAL LESION WAS TARGETED AND WHEN THE NEEDLE FIRED, IT STRUCK THE DETECTOR. THE BIOPSY WAS SUCCESSFULLY COMPLETED AND NO ADDITIONAL INTERVENTION WAS REQUIRED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND IT WAS DETERMINED THAT AFTER A SOFTWARE UPGRADE THE NEEDLE PARAMETERS WERE NOT ENABLED. THE TECHNOLOGIST SELECTED AN EVIVA 9G X13CM PETITE THINKING IT WAS THE SAME AS EVIGA 9GX13CM STANDARD 20MM, WHICH WAS NOT AVAILABE/VISIBLE BECAUSE IT WAS NOT YET ENABLED. THE CORRECT NEEDLE TYPE WAS ENABLED IN THE APPLICATION. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601140 ↗
• MalfunctionApr 29, 2019Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT "THE BCM MONITOR IS FLICKERING AND WILL CHANGE VIEWS AND SOMETIMES THE TARGETS." NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560945 ↗
• MalfunctionApr 19, 2019Imprecision; Imprecision

  IT WAS INITIALLY REPORTED THAT "NEEDLE ARM NEEDS ADJUSTMENT, NOT SITTING PROPERLY." ADDITIONAL INFORMATION OBTAINED ON (B)(6) 2019 NOTED THAT WHEN THE BIOPSY WAS COMPLETED THE PATIENT WAS RELEASED FROM THE COMPRESSION AND IT WAS NOTED THAT THE NEEDLE HAD PENETRATED THE BREAST AND IMPACTED THE DETECTOR COVER. THE PATIENT HAD NOT FELT ANYTHING DURING THE BIOPSY AND NO MEDICAL INTERVENTION WAS NEEDED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THAT THE BCM AND BGM BOARD NEEDED TO BE REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532548 ↗
• MalfunctionMar 13, 2019Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE NEEDLE PENETRATED THROUGH THE PATIENT BREAST AND CONTACTED THE DETECTOR COVER, NO WARNING WAS RECEIVED. A STERI-STRIP WAS APPLIED TO THE BREAST AND NO MEDICAL INTERVENTION WAS NEEDED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THAT GUIDANCE HARDWARE, GEOMETRY, AND STX RECALIBRATION WAS NEEDED. ONCE THIS WAS COMPLETED, THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417192 ↗
• MalfunctionAug 29, 2018Imprecision; Calibration Problem; Imprecision; Calibration Problem

  IT WAS REPORTED THAT DURING A BIOPSY EXAM, THE TARGET APPEARED CORRECT, BUT THE NEEDLE WAS FURTHER IN THE BREAST. THE BIOPSY WAS COMPLETED SUCCESSFULLY AND NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND DETERMINED THAT RECALIBRATION WAS NEEDED. ONCE THIS WAS COMPLETED, THE SYSTEM WAS WORKING AS INTENDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7828659 ↗
• MalfunctionAug 7, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT ERRORS WERE OCCURRING DURING QC, BUT WAS ABLE TO EVENTUALLY PASS. DURING A PATIENT BIOPSY THE TARGETS APPEARED CORRECT, BUT WHEN THE NEEDLE WAS FIRED IT WENT BEYOND THE TARGET TO THE OTHER SIDE OF THE BREAST. BRUISING WAS NOTED. PRESSURE WAS APPLIED TO THE AREA AND NO FURTHER MEDICAL INTERVENTION WAS NEEDED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND IT WAS DETERMINED THAT THE ZENNER DIODE WAS WEAK AND NEEDED TO BE JUMPED AND THE BREAST PLATFORM WAS REPLACED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED. PER THE TECHNOLOGIST A FOLLOW UP CALL IS MADE TO PATIENTS THE NEXT DAY FOR RESULTS AND SHE WAS NOT INFORMED OF ANY FURTHER ISSUES.

  Patient problems: Bruise/Contusion

  MAUDE report 7758120 ↗
• MalfunctionApr 5, 2018Installation-Related Problem; Installation-Related Problem

  IT WAS REPORTED THAT FOLLOWING A SOFTWARE UPGRADE, THE NEEDLE OPTIONS AND PARAMETERS WERE NOT RE-ENTERED INTO THE SYSTEM. DURING A BIOPSY PROCEDURE THE PATIENT BEGAN BLEEDING DURING SAMPLING AFTER THE NEEDLE PENETRATED AN ARTERY IN THE PATIENT'S BREAST. PRESSURE WAS APPLIED TO THE BREAST TO CONTROL THE BLEEDING AND THE PATIENT WAS EVALUATED BY A DOCTOR AND BREAST SURGEON ON SITE AND DETERMINED THAT NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WILL NEED TO RETURN FOR A REPEAT BIOPSY. IT WAS REPORTED BY THE CUSTOMER THAT THE DOCTOR DID NOTICE THAT THEIR NEEDLE SELECTION WAS NOT AVAILABLE IN THE SYSTEM, BUT THEY CONTINUED WITH THE BIOPSY. FOLLOWING THIS EVENT THE SITE SPOKE WITH AN APPLICATIONS SPECIALIST OVER THE PHONE WHO WALKED THEM THROUGH ENTERING THEIR NEEDLE SELECTIONS AND PARAMETERS. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND EVALUATED THE SYSTEM. HE FOUND THE SYSTEM TO BE WORKING AS INTENDED AND THE NEEDLE PARAMETERS TO BE CORRECT AFTER BEING LOADED BY THE SITE STAFF.

  Patient problems: Not Applicable

  MAUDE report 7399579 ↗
• MalfunctionFeb 24, 2018Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT THE Z AXIS WAS OFF AND DURING A BIOPSY PROCEDURE THE NEEDLE WENT THROUGH THE PATIENT BREAST. IT WAS NOTED THAT THE IMAGING DURING THE BIOPSY WAS OFF FROM THE INTENDED TARGET. IT WAS NOT REALIZED THAT THE NEEDLE HAD GONE THROUGH THE PATIENT BREAST UNTIL AFTER THE CASE WHEN THE TECH NOTICED A "SMALL NICK" ON THE MEDIAL SIDE OF THE BREAST WHEN THE BIOPSY NEEDLE SITE WAS ON THE LATERAL SIDE. NO MEDICAL INTERVENTION WAS NEEDED. THE AFFIRM UPRIGHT SYSTEM AND BREAST TRAY WERE REPLACED.

  Patient problems: Not Applicable

  MAUDE report 7294176 ↗
• MalfunctionFeb 23, 2018Device Operational Issue; Device Operational Issue

  IT WAS REPORTED BY THE FE THAT DURING A BIOPSY PROCEDURE THE NEEDLE PENETRATED THE PATIENT BREAST AND IMPACTED THE DETECTOR COVER. THE SAFETY LIMIT ALARM DID NOT INFORM THE TECH THAT THE NEEDLE WOULD HIT THE DETECTOR WHEN FIRED. THIS WAS REPORTED AS NO PATIENT INJURY AND IT IS UNKNOWN IF THE PATIENT REQUIRED ANY FURTHER MEDICAL ATTENTION.

  Patient problems: Not Applicable

  MAUDE report 7293976 ↗