Emprint CA20L2 (UDI 10884521806559)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10884521806559), received between Aug 7, 2020 and Aug 6, 2026 — classified as 2 deaths, 29 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (17 reports).

3 other recalls cover devices cleared under the same FDA submission (K163105); they may or may not involve this specific model.

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 52 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Device Alarm System; Adverse Event Without Identified Device or Use Problem

  It was reported that during an ablation procedure, the error code ¿antenna temperature limit exceeded¿ was displayed and recurred. The antenna was not used extensively, but it showed this error during two prior ablations, one time with 150W for 10 minutes. One time with 150W for 7 minutes. It was reported that the cooling saline had been cooled in a refrigerator, the pump was running, and the cooling saline did not heat up and the procedure was followed as instructed. It was reported that after several resets, the ablation could be finished with a positive result; however, the error occurred again in retract mode, but the track ablation was nearly finished, therefore, the surgeon saw the ablation as completed. The generator worked well with a new antenna.

  Patient problems: Insufficient Information

  MAUDE report 50159490 ↗
• InjuryJan 28, 2026Difficult or Delayed Activation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE FAILED TO DELIVER POWER. THE ENERGY COULD NOT REACH THE LESION. RESTARTED THE EQUIPMENT, REPLACED THE POWER CORD, AND REMOVED/DISCONNECTED THE ANTENNA CABLE. DESPITE THESE INTERVENTIONS, WHEN ATTEMPTING TO PERFORM A SUPERFICIAL ABLATION, IT WAS FOUND THAT NO POWER WAS BEING DELIVERED TO THE TISSUE, MAKING IT IMPOSSIBLE TO CONTINUE THE PROCEDURE WITH THIS SYSTEM. THE PROCEDURE CONTINUED WITHOUT THE USE OF TECHNOLOGY. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198893 ↗
• InjuryOct 15, 2025Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS NOT DETECTED BY THE GENERATOR. THE ERROR MESSAGE "ANTENNA NOT IDENTIFIED" APPEARED WHEN THE ANTENNA WAS CONNECTED TO THE CABLE, AND SINCE NO BACKUP ANTENNA WAS AVAILABLE, THE PROCEDURE WAS CANCELLED WHILE THE PATIENT WAS UNDER ANESTHESIA. THE PROCEDURE WILL BE RESCHEDULED, BUT NO DATE HAS BEEN CHOSEN YET. FUNCTIONAL TESTING WITH THE ALTERNATE ANTENNA CONFIRMED THAT THE GENERATOR, PUMP, AND REUSABLE CABLE WERE WORKING CORRECTLY.

  Patient problems: Insufficient Information

  MAUDE report 23277891 ↗
• InjuryJun 9, 2025Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING LIVER TUMOR ABLATION, THE UNIT DISPLAYED AN ERROR INDICATING THE ANTENNA COULD NOT BE IDENTIFIED. AND UPON INSPECTION, TWO INTERNAL PRONGS OF THE CONNECTOR ON THE ANTENNA WERE FOUND TO BE BROKEN/MISSING. THE CASE WAS ABORTED; PATIENT WAS UNDER ANESTHESIA. THE PROCEDURE WAS RESCHEDULED.

  Patient problems: Insufficient Information

  MAUDE report 22170391 ↗
• MalfunctionApr 7, 2025No Flow; No Flow

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE NEEDLE, WHICH NEEDED TO COOL AT THE TIME OF ABLATION, DID NOT FUNCTION PROPERLY DUE TO A FAILURE IN THE CIRCULATION OF SALINE SOLUTION (NO RETURN OF SALINE SOLUTION TO THE SYSTEM). IT WAS NECESSARY TO OPEN ANOTHER KIT THAT WORKED NORMALLY, ALLOWING THE PROCEDURE TO BE COMPLETED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21786321 ↗
• MalfunctionFeb 18, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE USE, THE DEVICE BROKE CLOSE TO THE TIP DURING THE EXIT OF THE ABLATION ANTENNA. IT WAS NOTED THAT THE PROCEDURE WAS ABLE TO BE COMPLETED DESPITE THE COMPONENT ISSUE. THE BREAKAGE WAS POSSIBLY DUE TO EXCESS FORCE AND CURVATURE, BUT CONFIRMATION WAS NEEDED. THE ANTENNA SHEATH OR ANY PART OF THE DEVICE DID NOT COMPLETELY DETACH, AND THE BROKEN PIECE DID NOT FALL INTO THE PATIENT CAVITY. THERE WAS NO NEED TO PERFORM AN X-RAY TO LOCATE OR RETRIEVE THE PIECE, AND NO ADDITIONAL MEDICAL PROCEDURE WAS REQUIRED TO REMOVE IT. THERE WAS NO PATIENT INJURY. THE PHOTO SHOWS A DAMAGED INTO SHAFT INSULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399563 ↗
• MalfunctionFeb 18, 2025Connection Problem; No Flow; Connection Problem; No Flow

  IT WAS REPORTED THAT DURING A LIVER CANCER TREATMENT USING THE DEVICE, SEVERAL ISSUES WERE ENCOUNTERED WITH THE ABLATION PUMP. THE COOLING WATER DID NOT CIRCULATE DESPITE THE PUMP MOTOR ROTATING, AND THE MECHANISM ON THE BOTTOM OF THE PUMP DID NOT MOVE UPWARDS EVEN WHEN THE LID WAS CLOSED. ADDITIONALLY, THE TUBE WAS NOT CLAMPED, REQUIRING THE DOCTOR TO MANUALLY HOLD IT DOWN. DESPITE THESE ISSUES, THE ABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395109 ↗
• MalfunctionFeb 18, 2025Leak/Splash; No Flow; Leak/Splash; No Flow

  IT WAS REPORTED THAT, DURING ABLATION, A VISUALIZATION OF WATER LEAKAGE AT THE BASE OF THE ANTENNA AFTER TREATING THE FIRST LESION. ADDITIONALLY, THERE WERE CIRCULATION ISSUES, INCLUDING A FAILURE TO CIRCULATE, DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393529 ↗
• InjuryJan 23, 2025Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING PERCUTANEOUS MICROWAVE ABLATION OF A LIVER TUMOR, THE DEVICE BROKE. AFTER A PROPERLY PERFORMED PROCEDURE AND COMPLETION OF THE ABLATION, AFTER REMOVING THE ANTENNA FROM THE PATIENT'S BODY, THE FINAL SECTION OF THE ANTENNA SHEATH WITH THE TROCAR TIP WAS MISSING AND DISENGAGED INTO PATIENT'S CAVITY. AFTER A FOLLOW-UP ULTRASOUND, THE PRESENCE OF A FOREIGN BODY IN THE LIVER PARENCHYMA WAS FOUND. THE PIECE WAS NOT RETRIEVED, AND THE PATIENT WAS INFORMED THAT THE ANTENNA SHEATH WITH THE TROCAR TIP WAS INSIDE THE BODY. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME ANTENNA.

  Patient problems: Foreign Body In Patient

  MAUDE report 21223385 ↗
• DeathNov 26, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE GENERATOR FLASHES THE GENERAL WARNING ALERT IN RED AND IT DID NOT REACH THE TEMPERATURE. CUSTOMER RESTARTED THE GENERATOR, THEN TURNED OFF AND DISCONNECTED THE GENERATOR AND CART FOR TEN MINUTES AS THE MANUAL INDICATES, TRIED THIS THREE TIMES, THEN USED A DIFFERENT ANTENNA AND A NEW AND COLD BAG OF ONE LITER OF SALINE SOLUTION, AS IT DIDN'T WORK AGAIN, TRIED DOING THE SAME STEPS, VERIFIED PROPER CONNECTION OF REUSABLE CABLE TO GENERATOR, ENSURED THE COOLING PUMP WAS ON AND CHANGED THE OUTLET WERE IT WAS CONNECTED. THE PROCEDURE WAS ABORTED-PATIENT WAS UNDER ANESTHESIA. HOWEVER, THE ANTENNA COULD NOT BE REMOVED BECAUSE THE PATIENT WAS BLEEDING TOO MUCH, SURGEON USED AN ELECTROCAUTERY TO CAUTERIZE THE BLEEDING; IT DIDN'T STOP, HAD TO MAINTAIN PRESSURE WITH GAUZE; PUT SEVERAL GAUZES INSIDE THE PATIENT AND KEPT THEM INSIDE FOR TWO DAYS IN ORDER TO STOP THE BLEEDING. SURGEON DECIDED TO TAKE THE PATIENT TO ANOTHER PRIVATE HOSPITAL BY AMBULANCE TO THE INTENSIVE CARE UNIT. THE PATIENT LEFT THE HOSPITAL IN A STABLE CONDITION AS INDICATED BY THE DOCTOR BUT OF COURSE THE CASE WAS DELICATE AS BLEEDING WAS PACKAGED. THE PATIENT HAS DIED AND THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20787410 ↗
• DeathNov 26, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE GENERATOR FLASHES THE GENERAL WARNING ALERT IN RED AND IT DID NOT REACH THE TEMPERATURE. CUSTOMER RESTARTED THE GENERATOR, THEN TURNED OFF AND DISCONNECTED THE GENERATOR AND CART FOR TEN MINUTES AS THE MANUAL INDICATES, TRIED THIS THREE TIMES, THEN USED A DIFFERENT ANTENNA AND A NEW AND COLD BAG OF ONE LITER OF SALINE SOLUTION, AS IT DIDN'T WORK AGAIN, TRIED DOING THE SAME STEPS, VERIFIED PROPER CONNECTION OF REUSABLE CABLE TO GENERATOR, ENSURED THE COOLING PUMP WAS ON AND CHANGED THE OUTLET WERE IT WAS CONNECTED. THE PROCEDURE WAS ABORTED-PATIENT WAS UNDER ANESTHESIA. HOWEVER, THE ANTENNA COULD NOT BE REMOVED BECAUSE THE PATIENT WAS BLEEDING TOO MUCH, SURGEON USED AN ELECTROCAUTERY TO CAUTERIZE THE BLEEDING; IT DIDN'T STOP, HAD TO MAINTAIN PRESSURE WITH GAUZE; PUT SEVERAL GAUZES INSIDE THE PATIENT AND KEPT THEM INSIDE FOR TWO DAYS IN ORDER TO STOP THE BLEEDING. SURGEON DECIDED TO TAKE THE PATIENT TO ANOTHER PRIVATE HOSPITAL BY AMBULANCE TO THE INTENSIVE CARE UNIT. THE PATIENT LEFT THE HOSPITAL IN A STABLE CONDITION AS INDICATED BY THE DOCTOR BUT OF COURSE THE CASE WAS DELICATE AS BLEEDING WAS PACKAGED. THE PATIENT HAS DIED AND THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20786310 ↗
• InjurySep 27, 2024Leak/Splash; Failure to Fire; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Failure to Fire; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE ANTENNA HAD NO ALARM. PROCEDURE WAS ABORTED. VIDEOS AND PHOTO WERE SUBMITTED SHOWING ANTENNA HAD LEAK.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321512 ↗
• InjurySep 11, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING PROCEDURE, ATTEMPTED ABLATION ON CAGEN1 GENERATOR AND UNABLE TO ABLATE WITH A "?" ERROR. SWITCHED TO EMPRINT SX MACHINE AND RECEIVED ANTENNA STATE = 4 THERMAL LIMIT EXCEEDED AND ABLATION STATE = 16 GENERAL ERROR CODES. AFTER OPENING THE THIRD ANTENNA AND UNABLE TO ABLATE, THE PROCEDURE WAS ABORTED (PATIENT UNDER ANESTHESIA) AND PATIENT WAS UNABLE TO GET ABLATION PROCEDURE, BUT THE SURGEON MOVED FORWARD WITH DISSECTION PROCEDURE/LIVER RESECTION. LESION REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 20196018 ↗
• InjurySep 11, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING PROCEDURE, ATTEMPTED ABLATION ON CAGEN1 GENERATOR AND UNABLE TO ABLATE WITH A "?" ERROR. SWITCHED TO EMPRINT SX MACHINE AND RECEIVED ANTENNA STATE = 4 THERMAL LIMIT EXCEEDED AND ABLATION STATE = 16 GENERAL ERROR CODES. AFTER OPENING THE THIRD ANTENNA AND UNABLE TO ABLATE, THE PROCEDURE WAS ABORTED (PATIENT UNDER ANESTHESIA) AND PATIENT WAS UNABLE TO GET ABLATION PROCEDURE, BUT THE SURGEON MOVED FORWARD WITH DISSECTION PROCEDURE/LIVER RESECTION. LESION REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 20195721 ↗
• MalfunctionJul 25, 2024Device Alarm System; Leak/Splash; No Flow; Device Alarm System; Leak/Splash; No Flow

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE CIRCULATION SYSTEM PRESENTED FAILURES, INCLUDING AIR BUBBLES IN THE COOLING SYSTEM THAT APPEARED DURING THE PROCEDURE, AND CAUSED TEMPERATURE ALARM BECAUSE OF IMPOSSIBILITY TO COOL PROPERLY THE ANTENNA. LEAKS WERE PRESENT. DEVICE BROKE PRIOR TO USE ON PATIENT. PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829586 ↗
• InjuryJul 12, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE ABLATION WAS SET FOR 150WATT AND 10 MIN, THE GENERATOR ACTIVATED A TEMPERATURE ALARM SYSTEM ERROR STOPPING THE TREATMENT AT 3 MIN. THE COOLING WATER SYSTEM HAD BEEN CHECKED AND FOUND NO DEFAULT OF INSTALLATIONS. THE WATER HAD BEEN CHANGED. A SECOND ANTENNA WAS OPENED AND TESTED, AND THE ALARM RANG DIRECTLY. AT THAT POINT, IT WAS NOT POSSIBLE TO IDENTIFY IF THE CAUSE WAS THE REUSABLE CABLE, THE GENERATOR OR THE PUMP. ALL THREE WERE TESTED SEPARATELY TO DETERMINE WHICH ONE SHOULD RECEIVE MAINTENANCE. TWO DIFFERENT ANTENNAS HAD BEEN USED WITHOUT EFFECT DURING THESE PROCEDURES. THE BIOMEDICAL ENGINEER TESTED A SECOND ANTENNA, A SECOND REUSABLE CABLE, AND A SECOND WATER COOLING UNIT, ALL LEADING TO THE SAME TEMPERATURE ERROR. HOWEVER, IN A SECOND TIME, SALES REP DID A SECOND TEST SESSION, WHERE TRIED TO ASSESS IF IT WAS THEIR GENERATOR THAT WAS AT THE ORIGIN OF THE PROBLEM, BY COMPARING WITH THE DEMONSTRATION OF THE UNIT. APPEARED THAN THE SAME ALARM OCCURRED WITH THE GENERATOR. TWO ANTENNAS USED DURING THE ISSUE SHARED THE SAME SERIAL NUMBER. TRIED WITH A DIFFERENT SERIAL NUMBER ANTENNA, NO TEMPERATURE ALARM OCCURRED ON THE GENERATOR

  Patient problems: Insufficient Information

  MAUDE report 19735643 ↗
• InjuryJul 12, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE ABLATION WAS SET FOR 150WATT AND 10 MIN, THE GENERATOR ACTIVATED A TEMPERATURE ALARM SYSTEM ERROR STOPPING THE TREATMENT AT 3 MIN. THE COOLING WATER SYSTEM HAD BEEN CHECKED AND FOUND NO DEFAULT OF INSTALLATIONS. THE WATER HAD BEEN CHANGED. A SECOND ANTENNA WAS OPENED AND TESTED, AND THE ALARM RANG DIRECTLY. AT THAT POINT, IT WAS NOT POSSIBLE TO IDENTIFY IF THE CAUSE WAS THE REUSABLE CABLE, THE GENERATOR OR THE PUMP. ALL THREE WERE TESTED SEPARATELY TO DETERMINE WHICH ONE SHOULD RECEIVE MAINTENANCE. TWO DIFFERENT ANTENNAS HAD BEEN USED WITHOUT EFFECT DURING THESE PROCEDURES. THE BIOMEDICAL ENGINEER TESTED A SECOND ANTENNA, A SECOND REUSABLE CABLE, AND A SECOND WATER COOLING UNIT, ALL LEADING TO THE SAME TEMPERATURE ERROR. HOWEVER, IN A SECOND TIME, SALES REP DID A SECOND TEST SESSION, WHERE TRIED TO ASSESS IF IT WAS THEIR GENERATOR THAT WAS AT THE ORIGIN OF THE PROBLEM, BY COMPARING WITH THE DEMONSTRATION OF THE UNIT. APPEARED THAN THE SAME ALARM OCCURRED WITH THE GENERATOR. TWO ANTENNAS USED DURING THE ISSUE SHARED THE SAME SERIAL NUMBER. TRIED WITH A DIFFERENT SERIAL NUMBER ANTENNA, NO TEMPERATURE ALARM OCCURRED ON THE GENERATOR

  Patient problems: Insufficient Information

  MAUDE report 19735548 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PROCEDURE WAS PERFORMED AFTER A 4 HOUR CHEMO EMBOLIZATION. AFTER THE ABLATION THE CUSTOMER SHOWED WITH THE US AND THE ANGIOGRAPH THAT THE ABLATION WAS FINE, AND EVERYTHING WAS OK. ON THE FOLLOW-UP AFTER, THE STAFF SHOWED ON A CT SCAN SOMETHING IN THE LIVER WHICH THEY THINK THAT IT CAN BE SOMETHING FROM THE ANTENNA OR FROM THE CHEMO DRUGS. THE PROCEDURE WAS COMPLETED WITH THE SAME INCIDENT DEVICE. IT WAS NOTED THAT AFTER THE PROCEDURE THERE WAS NO INDICATION OF A FAILURE OR DETACH OF ANY PART OF THE ANTENNA. PHOTOGRAPH WAS RECEIVED AND SHOWED THE UNKNOWN PARTICLE ON THE SCAN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19292753 ↗
• InjuryApr 15, 2024Device Alarm System; Failure to Fire; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Failure to Fire; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER A GENERATOR SHUT DOWN OF 1H, IT HAD BEEN RESTARTED FOR ANOTHER PATIENT. SAME GENERAL ALARM WAS PRESENT FROM THE START THIS TIME, BUT ONLY ON THE 100W SETTING. NO ALARM ON 75W SETTING, SO THE PROCEDURE HAD BEEN STARTED, BUT ABORTED BECAUSE THE PHYSICIAN HAD NO SIGN OF TREATMENT ON PER OP MEDICAL IMAGING (ULTRASOUND AND CT SCAN CONTROL), SO IT SEEMS 75W DID NOT WORK DESPITE LACK OF ALARM (2 ANTENNAS HAD BEEN USED DURING THIS PROCEDURE). THE PATIENT HAD TO BE RESCHEDULED AND TREATED.

  Patient problems: Insufficient Information

  MAUDE report 19112190 ↗
• InjuryApr 5, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, TEMPERATURE ALARM ACTIVATED AT THE ANTENNA CONNECTION, WHEN ALREADY POSITIONED IN THE PATIENT, EVEN AFTER ANTENNA CHANGED AND COOLING SYSTEM CHECKED, NO EFFECT FROM RESET BUTTON. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 19050888 ↗
• InjuryApr 5, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, TEMPERATURE ALARM ACTIVATED AT THE ANTENNA CONNECTION, WHEN ALREADY POSITIONED IN THE PATIENT, EVEN AFTER ANTENNA CHANGED AND COOLING SYSTEM CHECKED, NO EFFECT FROM RESET BUTTON. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 19050523 ↗
• InjuryApr 2, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, TEMPERATURE ALARM ACTIVATED AT THE ANTENNA CONNECTION (ELECTRONIC AND WATER COOLING SET), WHEN ALREADY POSITIONED IN THE PATIENT, EVEN AFTER ANTENNA WAS CHANGED, AND COOLING SYSTEM WAS CHECKED, THERE WAS NO EFFECT FROM RESET BUTTON. THE TWO ANTENNAS HAVE BEEN OPENED AND USED, AND THE REUSABLE CABLE SEEMED TO BE THE CAUSE OF THE FAILURE. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 19028201 ↗
• InjuryApr 2, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, TEMPERATURE ALARM ACTIVATED AT THE ANTENNA CONNECTION (ELECTRONIC AND WATER COOLING SET), WHEN ALREADY POSITIONED IN THE PATIENT, EVEN AFTER ANTENNA WAS CHANGED, AND COOLING SYSTEM WAS CHECKED, THERE WAS NO EFFECT FROM RESET BUTTON. THE TWO ANTENNAS HAVE BEEN OPENED AND USED, AND THE REUSABLE CABLE SEEMED TO BE THE CAUSE OF THE FAILURE.THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 19027874 ↗
• MalfunctionDec 22, 2023No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THE DEVICE HAD WATERLINE ABNORMALITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18385267 ↗
• MalfunctionDec 19, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, THERE WERE SOME MOISTURE BUILD UP IN THE SOFT TISSUES WHEN THE NEEDLE WAS IN THE PATIENT. WHEN REMOVING THE NEEDLE, THERE WERE TRICKLES OF WATER RUN OUT OF THE NEEDLE. NO SODIUM CHLORIDE (NACL) CAME THROUGH THE END OF THE NEEDLE, BUT A BRANCH EARLIER WHEN THE NEEDED WAS TESTED. IT APPEARED THAT THERE WAS NO WATER AT THE END OF THE NEEDLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18358320 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163105. One submission often covers many models, so check the product and lot details in each record.

• Z-0626-2019 · Nov 15, 2018 · Open, Classified
  Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation)
• Z-0625-2019 · Nov 15, 2018 · Open, Classified
  Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) o
• Z-0627-2019 · Nov 15, 2018 · Open, Classified
  Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of sof