ENCOR ENSPIRE® E4115Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00801741086113), received between Jan 12, 2017 and May 22, 2026 — classified as 2 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Application Program Problem

  IT WAS REPORTED THAT THE ENCOR FOOT PEDAL VACUUM BUTTON WAS NOT WORKING DURING TWO MAMMOGRAM PROCEDURES. DURING THE FIRST PROCEDURE, THE USER FORGOT THAT THE ENCOR DRIVER ALSO HAD THE VACUUM BUTTON, SO THE USER SKIPPING THE VACUUMING AFTER SAMPLING WHICH CAUSED A 2.3 CM HEMATOMA. DURING THE SECOND PROCEDURE, AFTER THEY SAW ANOTHER HEMATOMA FOR THE SECOND PATIENT, THEN THEY USED THE VACUUM BUTTON ON THE ENCOR DRIVER AND WAS ABLE TO REMOVE THE ADDITIONAL FLUID IN THE BREAST. BECAUSE OF THIS THE SECOND PATIENT HEMATOMA WAS NOT AS SIGNIFICANT. AS THE ENSPIRE SN: (B)(6) WAS USED DURING BOTH PROCEDURES, AND IT IS UNKNOWN WHETHER THE FOOT PEDAL OR THE ENSPIRE CAUSED THE ISSUE. IT WAS IDENTIFIED THAT ENCOR ENSPIRE SN: (B)(6) AND ENCOR FOOT PEDAL SN: (B)(6) WERE BOTH USED TOGETHER AS A SYSTEM DURING BOTH EVENTS LISTED ABOVE. THERE WAS PATIENT INJURY DURING THE TWO EVENTS SINCE BOTH PATIENTS WERE PRESENTED WITH HEMATOMAS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 25251666 ↗
• InjuryMay 22, 2026Application Program Problem

  IT WAS REPORTED THAT THE ENCOR FOOT PEDAL VACUUM BUTTON WAS NOT WORKING DURING TWO MAMMOGRAM PROCEDURES. DURING THE FIRST PROCEDURE, THE USER FORGOT THAT THE ENCOR DRIVER ALSO HAD THE VACUUM BUTTON, SO THE USER SKIPPING THE VACUUMING AFTER SAMPLING WHICH CAUSED A 2.3 CM HEMATOMA. DURING THE SECOND PROCEDURE, AFTER THEY SAW ANOTHER HEMATOMA FOR THE SECOND PATIENT, THEN THEY USED THE VACUUM BUTTON ON THE ENCOR DRIVER AND WAS ABLE TO REMOVE THE ADDITIONAL FLUID IN THE BREAST. BECAUSE OF THIS THE SECOND PATIENT HEMATOMA WAS NOT AS SIGNIFICANT. AS THE ENSPIRE SN (B)(6) WAS USED DURING BOTH PROCEDURES, AND IT IS UNKNOWN WHETHER THE FOOT PEDAL OR THE ENSPIRE CAUSED THE ISSUE. IT WAS IDENTIFIED THAT ENCOR ENSPIRE SN (B)(6) AND ENCOR FOOT PEDAL SN (B)(6) WERE BOTH USED TOGETHER AS A SYSTEM DURING BOTH EVENTS LISTED ABOVE. THERE WAS PATIENT INJURY DURING THE TWO EVENTS SINCE BOTH PATIENTS WERE PRESENTED WITH HEMATOMAS. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 25251664 ↗
• MalfunctionMar 5, 2026Application Program Problem

  IT WAS INITIALLY REPORTED THAT THE ENCOR DRIVER FAILED TO INITIALIZE AND STOPPED DETECTING THE PROBE WHILE IT WAS ATTACHED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL DETAILS INDICATE THAT THE ENCOR DRIVER FUNCTIONS INTERMITTENTLY, THEN STOPS SENSING THE NEEDLE AND RETURNS TO THE CALIBRATE SCREEN. WHEN THE USER POWERS ON THE ENCOR ENSPIRE SYSTEM, THE SYSTEM BOOTS UP AND DISPLAYS THE CALIBRATION SCREEN. THE USER ATTACHES THE NEEDLE AND DRIVER TO PERFORM CALIBRATION, AFTER WHICH THE SYSTEM ADVANCES TO THE SAMPLE SCREEN. THE USER PREFERS TO RUN SEVERAL TEST SAMPLES PRIOR TO BRINGING IN A PATIENT TO ENSURE THE NEEDLE IS FUNCTIONING PROPERLY. HOWEVER, DURING THE SAMPLE PATH PROCESS, THE SYSTEM UNEXPECTEDLY RETURNS TO THE CALIBRATION SCREEN. THE NEEDLE DOES NOT MOVE ON THE DRIVER OR LIFT OFF AT ANY POINT. IN SOME INSTANCES, THE DRIVER DOES NOT INITIALIZE UPON STARTUP, PARTICULARLY WHEN CHANGING A PORT. A DIFFERENT NEEDLE HAS BEEN TESTED ON THE ENCOR DRIVER. HOWEVER, ISSUE STILL PERSISTED. THE SALES REP CONFIRMED MULTIPLE NEEDLES WERE USED. SEPARATELY, IT WAS REPORTED THAT PRIOR TO PROCEDURE, THE ENCOR FOOT PEDAL'S BUTTONS WERE UNRESPONSIVE, AND EXPOSED WIRES OBSERVED AT THE BASE. ADDIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516088 ↗
• MalfunctionJan 21, 2026Application Program Problem; Physical Resistance/Sticking

  A 66 YEAR OLD FEMALE PATIENT UNDERWENT A STEREOTACTIC BREAST BIOPSY PROCEDURE USING THE ENCOR ENSPIRE SYSTEM. DURING THE PROCEDURE, ENCOR ENSPIRE SYSTEM UNEXPECTEDLY ENTERED INTO REBOOT MODE WHILE THE NEEDLE WAS INSIDE THE PATIENT'S BREAST. THE PROCEDURE WAS PERFORMED IN AN UPRIGHT POSITION USING VERTICAL APPROACH AT THE CC ANGLE. NO BUTTONS WERE PRESSED ON THE ENCOR FOOT PEDAL OR THE ENCOR DRIVER. WHILE THE NEEDLE WAS IN THE PATIENT'S BREAST AND THE RADIOLOGIST WAS PREPARING TO ADMINISTER ADDITIONAL LIDOCAINE, THE TECHNOLOGIST BELIEVES THE RADIOLOGIST MOVED THE CABLES OUT OF THE WAY BY THE NEEDLE. THEN, THE ENCOR ENSPIRE SYSTEM'S SCREEN SWITCHED TO A REBOOT MODE. SO, THE TECHNOLOGIST POWERED OFF THE ENCOR ENSPIRE SYSTEM AND INSTRUCTED THE RADIOLOGIST TO REMOVE THE LIDOCAINE SYRINGE AND WITHDRAW THE NEEDLE. FURTHERMORE, THE TECHNICIAN HAD POWERED THE ENCOR ENSPIRE SYSTEM BACK ON AND HAD TO REATTACH THE NEEDLE AND RECALIBRATE. THEN, THE TECHNICIAN ATTACHED THE NEEDLE AND THE RADIOLOGIST ADVANCED THE NEEDLE BACK INTO THE PATIENT'S BREAST TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141737 ↗
• MalfunctionDec 17, 2025Break; Application Program Problem; Break; Application Program Problem

  A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE THROUGH ENCOR ENSPIRE SYSTEM, IT WAS REPORTED THAT DURING A STEREOTACTIC VERTICAL APPROACH PROCEDURE WHILE IN "SAMPLE" MODE AND THEY HAVE ALREADY BEGUN TO SAMPLE THE PATIENT TISSUE, THE ENCOR ENSPIRE SYSTEM SUDDENLY REVERTED BACK TO THE "START CALIBRATION" SCREEN. THE USER HAS TO REMOVE THE NEEDLE TO RECALIBRATE AND RE-ENTER THE TISSUE TO COMPLETE THE PROCEDURE. THIS OCCURRED TWICE. IT WAS IDENTIFIED THAT ENCOR ENSPIRE SYSTEM SN (B)(6) ((B)(4)), ENCOR DRIVER SN UNK ((B)(4)) AND ENCOR FOOT PEDAL SN UNK ((B)(4)) WERE USED TOGETHER AS A SYSTEM DURING THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825500 ↗
• MalfunctionDec 17, 2025Break; Application Program Problem; Break; Application Program Problem

  A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE THROUGH ENCOR ENSPIRE SYSTEM, IT WAS REPORTED THAT DURING A STEREOTACTIC VERTICAL APPROACH PROCEDURE WHILE IN "SAMPLE" MODE AND THEY HAVE ALREADY BEGUN TO SAMPLE THE PATIENT TISSUE, THE ENCOR ENSPIRE SYSTEM SUDDENLY REVERTED BACK TO THE "START CALIBRATION" SCREEN. THE USER HAS TO REMOVE THE NEEDLE TO RECALIBRATE AND RE-ENTER THE TISSUE TO COMPLETE THE PROCEDURE. THIS OCCURRED TWICE.IT WAS IDENTIFIED THAT ENCOR ENSPIRE SYSTEM SN: (B)(6), ((B)(4)), ENCOR DRIVER SN: UNK, ((B)(4)) AND ENCOR FOOT PEDAL SN UNK ((B)(4)) WERE USED TOGETHER AS A SYSTEM DURING THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825423 ↗
• MalfunctionSep 4, 2025Application Program Problem; Application Program Problem

  A PATIENT UNDERWENT A STEREOTACTIC BIOPSY PROCEDURE USING ENCOR ENSPIRE SYSTEM AT VERTICAL APPROACH. DURING THE PROCURE, IT WAS REPORTED THAT THE ENCOR ENSPIRE SYSTEM RETURNED TO THE DRIVER READY SCREEN DURING SAMPLING AFTER CALIBRATION WAS COMPLETED. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS STILL INSIDE THE PATIENT. IMMEDIATELY BEFORE THE SCREEN CHANGED, THE FOOT PEDAL WAS BEING HELD DOWN. REPORTEDLY, THE ENCOR DRIVER HAD SUCCESSFULLY COMPLETED CALIBRATION PRIOR TO THE ISSUE. HOWEVER, THE SCREEN REVERTED TO THE DRIVER READY SCREEN BEFORE PROMPTING THE USER TO RECALIBRATE THE NEEDLE. THE PROCEDURE WAS COMPLETED BY REPLACING THE UNIT WITH ANOTHER ENCOR ENSPIRE SYSTEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22960998 ↗
• MalfunctionMay 6, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT THE ENCOR DRIVER IS WITHOUT FORCE TO ROTATE THE NEEDLE, PRODUCED AN ERROR DURING THE TIME EXAMINATION. IT WAS FURTHER REPORTED THAT THE ADDITIONAL INFORMATION WAS PROVIDED DURING TWO SEPARATE SAMPLING PROCEDURES. REPORTEDLY, THE ENCOR ENSPIRE SYSTEM EMITTED AN ERROR SOUND AND RETURNED TO THE NEEDLE CALIBRATION SCREEN WITHOUT DISPLAYING AN ERROR MESSAGE. FURTHERMORE, ALL CONSUMABLES WERE EXCHANGED BETWEEN THESE PROCEDURES. IT WAS POSSIBLE TO COMPLETE THE PROCEDURE WITH THE CHANGE OF DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966808 ↗
• MalfunctionMay 6, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT THE ENCOR DRIVER IS WITHOUT FORCE TO ROTATE THE NEEDLE, PRODUCED AN ERROR DURING THE TIME EXAMINATION. IT WAS FURTHER REPORTED THAT THE ADDITIONAL INFORMATION WAS PROVIDED DURING TWO SEPARATE SAMPLING PROCEDURES. REPORTEDLY, THE ENCOR ENSPIRE SYSTEM EMITTED AN ERROR SOUND AND RETURNED TO THE NEEDLE CALIBRATION SCREEN WITHOUT DISPLAYING AN ERROR MESSAGE. FURTHERMORE, ALL CONSUMABLES WERE EXCHANGED BETWEEN THESE PROCEDURES. IT WAS POSSIBLE TO COMPLETE THE PROCEDURE WITH THE CHANGE OF DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966801 ↗
• MalfunctionFeb 19, 2025Application Program Problem; Application Program Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DRIVER DID NOT CALIBRATE AND RETURNED TO THE START SCREEN WITHOUT ANY COMMAND. IT WAS FURTHER REPORTED THAT THE PEDAL CALIBRATED SUCCESSFULLY BUT ASKED US TO REMOVE THE DRIVER AFTER COLLECTING THE TWO TO THREE FRAGMENTS, FURTHERMORE, THE DRIVER CALIBRATES CORRECTLY, HOWEVER THE SYSTEM RETURNS TO THE HOME SCREEN WITHOUT ANY COMMANDS. REPORTEDLY, THE COMMUNICATION ISSUE HAS BEEN OCCURRED BETWEEN THE DRIVER OR FOOT PEDAL AND THE SOURCE OF COMMUNICATION FAILURE COULD NOT BE IDENTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407711 ↗
• MalfunctionFeb 10, 2025Break; Failure to Calibrate; Illegible Information; Break; Failure to Calibrate; Illegible Information

  IT WAS REPORTED THAT THE DEVICE IS ALLEGEDLY BROKEN, AND PART OF THE SERIAL NUMBER IS MISSING. IT WAS FURTHER REPORTED THAT THE USER ADVISED POSSIBLY A "5" RUBBED OFF. REPORTEDLY, ADDITIONAL INFORMATION WAS PROVIDED THAT SYSTEM DISPLAYED ERROR CODE 1011 (CALIBRATION ERROR) WHEN CONNECTED TO THE DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21341430 ↗
• MalfunctionJan 2, 2025Application Program Problem; Device Markings/Labelling Problem; Application Program Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, AFTER THE FIRST SAMPLE WAS TAKEN AND GOING FOR THE SECOND SAMPLE, THE SYSTEM HAD ALLEGEDLY DISPLAYED AN ERROR MESSAGE. IT WAS FURTHER REPORTED THAT AFTER THE FIRST INITIAL SAMPLE WAS EXECUTED, A CORE WAS PROVIDED. FURTHERMORE, THERE WERE NO INSTRUCTIONS GIVEN ON THE SCREEN TO CLEAR THE ERROR, SO THEY HAD TO TURN OFF THE SYSTEM MID-BIOPSY. MOREOVER, THE TECH AND NURSE CHECKED THE CANNISTERS AND ALL AREAS FOR KINKS/LOOSE CONNECTIONS AND COULD NOT FIND ANYTHING. IN ADDITION, THE PROBE WAS RECONNECTED TO THE DRIVER AND THEN THE BIOPSY WAS COMPLETED WITH NO ISSUES AFTERWARDS. APPARENTLY, THE SERIAL NUMBER ¿0¿ OF ENSPIRE SYSTEM WAS RUBBED OFF SO THIS LETTER/NUMBER COULD BE A ¿D¿. EVIDENTLY, ADDITIONAL REVIEW OF THE LABEL REVEALED THAT THE SERIAL NUMBER AS WELL AS THE SAFETY INFORMATION WAS ALLEGEDLY BLURRED AND NOT LEGIBLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053634 ↗
• MalfunctionNov 4, 2024Application Program Problem; Unintended Movement; Application Program Problem; Unintended Movement

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, A PATTERN WAS SELECTED, HOWEVER THE UNIT IGNORED DESIRED PATTERN AND SAMPLED A FULL CLOCK ROTATION, AND THEN DEVICE STOPPED RESPONDING. IT WAS FURTHER REPORTED THAT THE TOUCHSCREEN, DRIVER AND PEDAL WERE ALL ALLEGEDLY STOPPED RESPONDING. IT HAS BEEN TURNED OFF AND BACK ON, DRIVER AND PEDAL DETACHED AND REATTACHED AND NEW NEEDLE LOADED AND STILL IT DOES NOT RESPOND. FURTHERMORE, WE HAD SET THE MACHINE TO AVOID THE 7:00 AND 9:00 POSITIONS. ALTHOUGH THE SCREEN SHOWED THOSE POSITIONS GRAYED OUT, THE NEEDLE DID NOT AVOID THESE AREAS WHEN SAMPLING. IT IGNORED THE PATTERN AND TOOK A FULL CLOCK SAMPLE INSTEAD. AFTER THE SAMPLES WERE TAKEN, THE NEEDLE BEGAN PULSE AS IF IT WAS STUCK AND THE UNIT STOPPED RESPONDING. WE USED THE FOOT PEDAL TO INITIATE SAMPLING. AFTER SAMPLES WERE TAKEN AND THE UNIT BECAME STUCK AND STOPPED RESPONDING, WE ATTEMPTED TO USE BOTH THE FOOT PEDAL AND THE SAMPLE BUTTON ON THE HAND PIECE TO RESET THE NEEDLE AND CHANGE TO MARKER POSITION BUT WERE UNSUCCESSFUL. WE WERE ABLE TO OBTAIN THE SAMPLES NEEDED, BUT THE MACHINE ALSO SAMPLED TWO POSITIONS THAT WE DID NOT INTEND TO SAMPLE. THE NEEDLE AND UNIT STOPPED RESPONDING AFTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20596959 ↗
• MalfunctionAug 6, 2024Device Difficult to Setup or Prepare; Improper or Incorrect Procedure or Method; Application Program Problem; Device Difficult to Setup or Prepare; Improper or Incorrect Procedure or Method; Application Program Problem

  IT WAS REPORTED THAT DURING A STEREOTACTIC GUIDED CORE BIOPSY ON GE UPRIGHT, SYSTEM'S MONITOR SCREEN ALLEGEDLY KEPT GOING BACK TO THE CALIBRATION SCREEN AND MAKING THE DEVICE TO CALIBRATE IN THE MIDDLE OF TAKING SAMPLES. IT WAS FURTHER REPORTED THAT ONCE IT SWITCHED OVER TO THE CALIBRATION SCREEN, THE USER WOULD PUSH THE FOOT PEDAL TO CALIBRATE. IT WAS ALSO REPORTED THAT THEY WERE THEN ABLE TO TAKE A COUPLE SAMPLES AT THAT TIME BUT, IT WOULD ALLEGEDLY GO BACK TO CALIBRATION SCREEN AGAIN PERIODICALLY, ALL WHEN THE NEEDLE WAS IN THE PATIENT'S BREAST. FURTHERMORE, THE DEVICE WOULD SWITCH BETWEEN CALIBRATION AND SAMPLING SCREEN. ADDITIONALLY, THE DEVICE ALLEGEDLY CALIBRATED FEW TIMES INSIDE THE PATIENT'S BREAST AND CALIBRATED FEW TIMES OUT OF THE PATIENT'S BREAST. MOREOVER, TROUBLESHOOTING WAS TRIED BY REPLACING THE NEEDLE; HOWEVER, THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED BY USING HOLOGIC NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19915658 ↗
• MalfunctionAug 25, 2022Device Difficult to Setup or Prepare; Mechanical Jam; Unintended Movement; Device Difficult to Setup or Prepare; Mechanical Jam; Unintended Movement

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY TOOK SAMPLES FROM THE WRONG QUADRANT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15291368 ↗
• MalfunctionMay 19, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE DEVICE BEGAN TAKING SAMPLES WITHOUT ANY BUTTON PUSHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14447028 ↗
• MalfunctionAug 9, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER THE PROBE WAS POSITIONED IN THE PATIENT, THE DEVICE ACTIVATED ON IT'S OWN AND COULD NOT BE STOPPED UNTIL IT HAD FINISHED THE ENTIRE 6 SAMPLES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292487 ↗
• MalfunctionJul 9, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE DRIVER ACTIVATED AND BEGAN SAMPLING WHILE IN THE HOLDER(SAMPLE BUTTON NOT BEING PRESSED) WAITING FOR THE PROCEDURE FOR ABOUT 20 MINUTES. NEEDLE WAS CHANGED, DRIVER PORT WAS CHANGED AND IT STILL HAD SAME ISSUE. DEVICE WAS THEN HOOKED UP TO AN ALTERNATE SYSTEM AND SEEMED TO CORRECT ITSELF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12141124 ↗
• MalfunctionMay 13, 2021Application Program Problem; Unintended Movement; Application Program Problem; Unintended Movement

  IT WAS REPORTED THAT THE DEVICE COMPLETED THE BASIC SET UP AND CALIBRATION OF THE PROBE IN STEREO MODALITY. WHILE IN SAMPLE MENU 3, USING THE MONITOR SCREEN DROP DOWN MENU FOR ADVANCED SETTINGS, THE TM SELECTED A SECTION ON THE SAMPLE CLOCK AND THE PROBE AND DRIVER GEARS BEGAN TO ROTATE WITHOUT INPUT FROM THE TM. TM TRIED TWICE TO MAKE SELECTIONS WITH THE SAME RESULT. DRIVER MADE GRINDING NOISES AND ROTATION OF THE PROBE, CUTTER DID NOT OPEN. THE FIRST TIME THE PROBE WAS KICKED OFF THE DRIVER, THE SECOND TIME THE PROBE STAYED ON THE DRIVER BUT BEGAN TO ROTATE UNTIL THE ERROR MESSAGE OF DRIVER FAILURE WAS DISPLAYED. WHEN DRIVER WAS MOVED FROM PORT 1 TO PORT 2 THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11818191 ↗
• MalfunctionFeb 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT POST BIOPSY PROCEDURE, THE CANISTER WAS ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371936 ↗
• MalfunctionDec 14, 2020Suction Problem; Unintended Movement; Suction Problem; Unintended Movement

  IT WAS REPORTED THAT DURING THE BIOPSY PROCEDURE, NO FRAGMENTS CAME IN THE COLLECTION BASKET. THE PHYSICIAN TRIED TO USE THE VACUUM TO ASPIRATE AND THE PUMP DID NOT WORK. REPORTEDLY, THE NEEDLE REMAINED IN THE SAME POSITION, BUT THE EQUIPMENT SCREEN SHOWED IT AS IF THE NEEDLE WAS SPINNING, EVEN AFTER RELEASING THE VACUUM CONTROL IT WAS STILL SHOWN AS ACTIVATED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002555 ↗
• MalfunctionDec 3, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A VACUUM ASSISTED BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD UNINTENDED CUTTING SEQUENCE INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10941056 ↗
• MalfunctionNov 19, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE EQUIPMENT NEEDLE SPONTANEOUSLY ACTIVATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10867656 ↗
• MalfunctionOct 30, 2020Application Program Problem; Application Program Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL E4115 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED APPLICATION PROGRAM PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10763895 ↗
• MalfunctionApr 17, 2019Failure to Calibrate; Unintended Movement; Failure to Calibrate; Unintended Movement

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL E4115 ENSPIRE SYSTEM ALLEGEDLY FAILED TO CALIBRATE AND EXPERIENCED UNINTENDED MOVEMENT. THIS REPORT WAS RECEIVED FROM ONE SOURCES. THERE WAS NO PATIENT INVOLVEMENT FOR THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8525470 ↗