ENCOR® DRENCORRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00801741086076), received between Jan 12, 2017 and May 13, 2026 — classified as 2 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (19 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE ENCOR ENSPIRE SYSTEM DISPLAYED TWO ERROR CODES, HANDPIECE MEMORY CANNOT READ AND SYSTEM ERROR 0066 WHEN CONNECTED TO THE ENCOR DRIVER. ADDITIONAL INFORMATION INCLUDED IMAGE OF THE DRENCOR SERIAL NUMBER WHICH SHOWS THE LAST DIGIT IS SLIGHTLY SMEARED MAKING IT DIFFICULT TO READ AND NOT CLEARLY LEGIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159455 ↗
• MalfunctionMar 5, 2026Break; Contamination; Crack; Material Discolored; Application Program Problem; Scratched Material

  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 24515939 ↗
• MalfunctionJan 21, 2026Application Program Problem

  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 24141740 ↗
• MalfunctionJan 5, 2026Unintended Movement

  A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE USING THROUGH THE ENCOR ENSPIRE SYSTEM'S. IT WAS REPORTED THAT DURING A STEREOTACTIC SETUP, THE ENCOR ENSPIRE SYSTEM'S TOUCHSCREEN WAS STICKING ON ONE OF THE SLICES LIKE IT WANTED TO SAMPLE THE SAME AREA TWICE. ADDITIONAL CLARIFICATION WAS RECEIVED STATED THAT THE TOUCHSCREEN WOULDN'T ADVANCE TO THE NEXT SAMPLE LOCATION, EVEN THOUGH MULTIPLE LOCATIONS WERE SELECTED BY THE USER, ONLY THE 12 O'CLOCK POSITION WAS BEING SAMPLED. THE 12 O'CLOCK POSITION WAS SAMPLED TWICE. THE USER KEPT ATTEMPTING TO SELECT THE NEXT SAMPLE LOCATION AND EVENTUALLY WAS ABLE TO COLLECT OTHER TISSUE SAMPLES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954549 ↗
• MalfunctionDec 17, 2025Contamination; Failure to Read Input Signal; Application Program Problem; Contamination; Failure to Read Input Signal; 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) (WO-(B)(4)), ENCOR DRIVER SN UNK (WO-(B)(4)) AND ENCOR FOOT PEDAL SN UNK (WO-(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 23825497 ↗
• MalfunctionDec 17, 2025Contamination; Failure to Read Input Signal; Application Program Problem; Contamination; Failure to Read Input Signal; Application Program Problem

  A PATIENT UNDERWENT A REUSABLE BIOPSY PROCEDURE USING 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), ENCOR DRIVER SN UNK AND ENCOR FOOT PEDAL SN UNK WERE USED TOGETHER AS A SYSTEM DURING THIS EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825414 ↗
• MalfunctionDec 3, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ENCOR DRIVER CONTINUED SAMPLING EVEN WHEN THE ENCOR ENSPIRE DISPLAYED ERROR CODE 1005 DRIVER BUTTON OR CONTACT STUCK DURING INITIALIZATION. IT WAS ALSO REPORTED THAT THE DRIVER BUTTON DID NOT RESPOND WHEN PRESSED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23702149 ↗
• MalfunctionOct 16, 2025Accessory Incompatible; Failure to Read Input Signal; Unintended Movement; Accessory Incompatible; Failure to Read Input Signal; Unintended Movement

  IT WAS REPORTED THAT DURING AN UPRIGHT VERTICAL STEREOTACTIC PROCEDURE, THE ENCOR DRIVER WOULD NOT STOP SAMPLING AFTER THE USER REMOVED THEIR FOOT OFF THE ENCOR FOOT PEDAL. THE ENCOR ENSPIRE NEEDED TO BE SWITCHED OFF TO STOP THE DRIVER FROM SAMPLING. AFTER THE ENSPIRE WAS SWITCHED BACK ON, ERROR CODE 1005 (DRIVER BUTTON OR CONTACT STUCK DURING INITIALIZATION) WAS DISPLAYED. THE ENSPIRE WAS SWITCHED OFF BEFORE REMOVING THE NEEDLE FROM THE PATIENT. THERE WAS PATIENT INVOLVEMENT WITH NO INJURY. IT WAS IDENTIFIED THAT THE ENCOR ENSPIRE , THE ENCOR FOOT PEDAL AND THE ENCOR DRIVER WERE USED TOGETHER AS A SYSTEM DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23307483 ↗
• 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 22961000 ↗
• MalfunctionJul 23, 2025Failure to Read Input Signal; Unintended Movement; Failure to Read Input Signal; Unintended Movement

  A PATIENT UNDERWENT FOR A STEREOTACTIC MAMMOGRAPHY BREAST BIOPSY PROCEDURE USING ENCOR DRIVER BY VERTICAL APPROACH. IT WAS REPORTED THAT THE DEVICE CONTINUED TO OPERATE WITHOUT ANY BUTTON BEING PRESSED. FURTHER CLARIFICATION WAS PROVIDED THAT DURING THE SAMPLING PROCESS, THE SAMPLE BUTTON ON EITHER THE ENCOR DRIVER OR THE ENCOR FOOT PEDAL FAILED TO RESPOND. THE ENCOR ENSPIRE SYSTEM WAS ULTIMATELY STOPPED THROUGH MANUAL INTERVENTION. THERE WAS NO PATIENT INJURY. DURING THE MIDDLE OF THE SAMPLING PROCESS, THE ENCOR DRIVER CONTINUED TO TAKE SAMPLES WITHOUT ANY USER INPUT AND DID NOT STOP SAMPLING, EVEN WITHOUT THE SAMPLE BUTTON BEING PRESSED. THE USER WAS UNABLE TO STOP THE ENCOR DRIVER THEREFORE, THE USER HAD TO COMPLETELY STOP THE ENCOR ENSPIRE SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575296 ↗
• 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 21966806 ↗
• 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 21966804 ↗
• MalfunctionApr 23, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT SAMPLING WAS CONDUCTED WITHOUT PUSHING SAMPLE BUTTON. REPLACED A PROBE WITH ANOTHER, AND PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ISSUE OCCURRED DURING SAMPLING. WHEN THE OPENER WAS CLOSED, DISCONNECTED THE NEEDLE AND REPLACED WITH ANOTHER NEEDLE. THEN PROCEDURE WAS COMPLETED. NO ERROR MESSAGES WERE DISPLAYED. A PATIENT WAS INVOLVED, HOWEVER THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889074 ↗
• 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 21407708 ↗
• InjuryJan 15, 2025Application Program Problem; Mechanical Jam; Application Program Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING A STEREOTAXIC GUIDED VACUUM ASSISTED BREAST BIOPSY PROCEDURE, THE EQUIPMENT ALLEGEDLY GENERATED AN ERROR ON THE SCREEN AND STOPPED WORKING CAUSING THE NEEDLE TO BECOME STUCK WITHIN THE PATIENT'S BREAST. IT WAS FURTHER REPORTED THAT AS THE NEEDLE WAS BEING REMOVED, TISSUE WAS IDENTIFIED DRAGGING FROM THE NEEDLE CAUSING THE TISSUE TO FURTHER BREAK AND PATIENT TO FEEL PAIN AND HAVE INCREASED BLEEDING REQUIRING 2% LIDOCANE BE ADMINISTERED. THE PATIENT IS REPORTEDLY STABLE AND WAS DISCHARGED HOME. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ERROR WAS A VACUUM ERROR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 21155781 ↗
• MalfunctionDec 27, 2024Accessory Incompatible; Application Program Problem; Unintended Movement; Accessory Incompatible; Application Program Problem; Unintended Movement

  IT WAS REPORTED THAT DURING A VACUUM ASSISTED EXCISION PROCEDURE, WHEN THE NEEDLE WAS PLACED IN THE BREAST, IT STARTED TO TAKE THE FIRST SAMPLE WHICH GAVE ALLEGEDLY AN ERROR REGARDING NEEDLE CUTTER NOT OPENING CORRECTLY, SO USER TOOK THE NEEDLE OUT THE PATIENT AND DETACHED AND CALIBRATED AGAIN, THEN WENT TO REPOSITION THE NEEDLE IN THE BREAST, THEN THE USER SAW THE NEEDLE ALLEGEDLY SPUN AROUND IN THE BREAST REALLY FAST LIKE A DRILL, FOLLOWED BY A FEW SPARKS WERE NOTICED. IT WAS FURTHER REPORTED THAT THE FOOT WAS ON PEDAL WHEN THE DRIVER STARTED DRILLING MOTION AND THEY LET GO OF THE PEDAL AND THE DRIVER CONTINUED TO DRILL AND THEN HAD TO REMOVE THE DRIVER/NEEDLE FROM THE PATIENT WHILE IT WAS STILL DRILLING. FURTHERMORE, AT THAT POINT THE NEEDLE WAS REMOVED FROM THE BREAST AND REPLACED THE NEEDLE AND THE ENCORE MACHINE WITH ANOTHER ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025065 ↗
• MalfunctionNov 4, 2024Failure to Read Input Signal; Unintended Movement; Failure to Read Input Signal; 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 20596956 ↗
• MalfunctionJul 17, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, WHILE USING ANESTHETIC MODE, THE DEVICE PERFORMED FOUR BIOPSIES AND SYSTEM ALLEGEDLY STARTED TAKING SAMPLES ON ITS OWN WITHOUT PRESSING ANY SAMPLE BUTTONS ON EITHER THE FOOT PEDAL OR DRIVER. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY CONTINUED TO SAMPLE WHEN OUT OF THE PATIENT'S BREAST EVEN WHEN THE STOP PEDAL WAS DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19768168 ↗
• MalfunctionDec 27, 2023Accessory Incompatible; Contamination; Mechanical Problem; Application Program Problem; Accessory Incompatible; Contamination; Mechanical Problem; Application Program Problem

  IT WAS REPORTED THAT POST A BIOPSY PROCEDURE, THE DRIVER WAS ALLEGEDLY CONTAMINATED WITH FLUID IN THE GEARS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18396467 ↗
• MalfunctionMay 18, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE REPEATEDLY KEPT FIRING BUT THE FUNCTIONALITY OF THIS DEVICE DOES NOT FIRE REPEATEDLY. IT WAS FURTHER REPORTED THAT MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, BUT NOT RESOLVED. THEREFORE, IT WAS ASSUMED THAT THE FACILITY TRIED TO REPORT WAS, THE DEVICE WAS REPEATEDLY SAMPLING, NOT REPEATEDLY FIRING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16951583 ↗
• MalfunctionMar 4, 2023Unintended Movement; Noise, Audible; Unintended Movement; Noise, Audible

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, WHILE TRYING TO DEPLOY THE MARKER, THE SYSTEM ALLEGEDLY TOOK TWO FURTHER SAMPLES WITHOUT PRESSING/SELECTING ANYTHING ON THE ENCOR SYSTEM, DRIVER OR FOOT PEDAL. ADDITIONALLY, IT WAS ALSO REPORTED THAT THERE WAS AN UNUSUAL SOUND COMING FROM THE DRIVER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483380 ↗
• MalfunctionNov 16, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PRIOR TO BIOPSY PROCEDURE, THE DEVICE IS ALLEGEDLY SAMPLING WITHOUT PRESSING BUTTONS AS SOON AS ATTACHED TO FIRE FORWARD. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803910 ↗
• MalfunctionOct 23, 2022Accessory Incompatible; Contamination; Accessory Incompatible; Contamination

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE IS ALLEGEDLY CONTAMINATED WITH BLOOD. IT WAS FURTHER REPORTED THAT THE DEVICE IS NOT TAKING SAMPLES WITHOUT PRESSING BUTTONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656506 ↗
• MalfunctionJul 21, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PRIOR TO A BREAST BIOPSY PROCEDURE, THE DEVICE AUTOMATICALLY STARTED CUTTING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15072516 ↗
• MalfunctionNov 7, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE SERIAL NUMBER ON THE INNER LABEL DID NOT MATCH WITH THE OUTER BOX SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758188 ↗