NEUWAVE NWC1US1NRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00853719006753), received between Apr 8, 2019 and Aug 7, 2026 — classified as 39 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Asystole

  MAUDE report 50177146 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LIVER ABLATION AND THE PATIENT EXPERIENCED ABDOMINAL WALL PAIN/BURN. THEY ARE CURRENTLY SURVEYING THE PATIENT FOR ANY FURTHER COMPLICATIONS. SURGEON BELIEVED IT COULD BE TIED TO THE ANGLE THAT THE PROBES WERE PLACED AT WITHIN THE PATIENT THAT LED TO THE POST-OP REACTION.

  Patient problems: Burn(s); Pain

  MAUDE report 20318093 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Activation Problem; Adverse Event Without Identified Device or Use Problem; Activation Problem

  IT WAS REPORTED THAT DURING A RENAL ABLATION PROCEDURES THAT ONE PATIENT DEVELOPED A URETIC STRICTURE AND A URINOMA. PER RADIOLOGIST "UPON REVIEW OF IMAGES, THE ABLATION ZONE EXTENDED 2-3CM FROM THE TIP WHICH IS REALLY UNUSUAL". NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16004489 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE LIVER ABLATION PROCEDURE, AS SOON AS THE UNIT WAS TURNED ON, THE PATIENT WENT INTO HEART BLOCK. THE PATIENTS HEART STOPPED BEATING FOR SEVEN SECONDS AND THEN ONCE THE MACHINE WAS TURNED OFF, SHE RECOVERED. SO THEY GAVE HER SOME MEDICATION TO TRY TO PREVENT IT FROM HAPPENING AGAIN AND THE SECOND IT WAS TURNED BACK ON AND THE MEDICATION STARTED TO WEAR OFF, IT HAPPENED AGAIN. THEY CONTINUED TO GIVE THE PATIENT MEDICATION UNTIL IT WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Heart Block; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14848859 ↗
• MalfunctionMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABLATION THERE WAS SOFT TISSUE DAMAGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14305247 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A KIDNEY MICROWAVE ABLATION, THERE WAS A NEGATIVE PATIENT OUT COME. THEY ARE PULLING DATA TO ENSURE THERE WASN'T ANY ISSUES BECAUSE THE PATIENT ALMOST DIED. THERE WAS PATIENT CONSEQUENCES.

  Patient problems: Low Blood Pressure/ Hypotension; Syncope/Fainting

  MAUDE report 13842877 ↗
• InjuryFeb 22, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THREE MONTHS POST OP THE PATIENT EXPERIENCED LOSS OF KIDNEY FUNCTION IN THE ABLATED KIDNEY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Renal Failure; Swelling/ Edema

  MAUDE report 13581544 ↗
• InjuryFeb 22, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THREE MONTHS POST OP THE PATIENT EXPERIENCED LOSS OF KIDNEY FUNCTION IN THE ABLATED KIDNEY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Renal Failure; Swelling/ Edema

  MAUDE report 13581111 ↗
• InjuryJul 23, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT POST-OP TO A KIDNEY ABLATION PROCEDURE, THE PATIENT EXPERIENCED A POST-OPERATIVE ABSCESS. ADDITIONAL TREATMENT IS CURRENTLY UNKNOWN.

  Patient problems: Abscess

  MAUDE report 12216683 ↗
• InjuryJul 9, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: THE EFFECT OF TUMOR SIZE AND LOCATION ON EFFICACY AND SAFETY OF USAND CT- GUIDED PERCUTANEOUS MICROWAVE ABLATION IN RENAL CELL CARCINOMAS AUTHORS: SEPIDEH SHAKERI1 · SOHRAB AFSHARI MIRAK1 · AMIRHOSSEIN MOHAMMADIAN BAJGIRAN1 · ALLAN PANTUCK2 · ANTHONY SISK3 · PREETI AHUJA1 · DAVID S. LU1 · STEVEN S. RAMAN1, CITATION: ABDOMINAL RADIOLOGY (2019) 44:2308¿2315 HTTPS://DOI.ORG/10.1007/S00261-019-01967-8. THIS STUDY COHORT AIMS TO EVALUATE THE EFFECT OF TUMOR SIZE AND CENTRAL LOCATION IN SHORT-TERM SAFETY AND EFFICACY OF PERCUTANEOUS CEUS- AND CT-GUIDED MWA IN BIOPSY-PROVEN RCC TUMORS. FROM JANUARY 2013 TO MARCH 2017, 56 CONSECUTIVE PATIENTS (44 MALES,25 FEMALES) MEDIAN AGE OF 66 YEARS (27¿93) WITH SUSPICIOUS RENAL MASSES,AND WHO UNDERWENT PERCUTANEOUS MWA, WERE INCLUDED IN THIS STUDY. THE TUMOR MICROWAVE ABLATION WAS PERFORMED USING ONE OR TWO COMMERCIALLY AVAILABLE 15-CM, 17-G NEEDLE ANTENNAS (NEUWAVE PR 15; NEUWAVE MEDICAL, MADISON, WIS) MATED TO A 2.45-GHZ MICROWAVE GENERATOR CAPABLE OF 65 W PER ANTENNA (CERTUS; NEUWAVE MEDICAL, MADISON, WIS). FOR EXOPHYTIC LESIONS 2 CM OR LESS, A SINGLE ANTENNA WAS GUIDED TO THE CENTER OF THE LESION, BISECTI

  Patient problems: Hematoma; Pain

  MAUDE report 12142615 ↗
• InjuryJul 8, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: PERCUTANEOUS THERMAL ABLATION OF SUBCAPSULAR HEPATOCELLULAR CARCINOMAS: INFLUENCE OF TUMOR-SURFACE CONTACT AND PROTRUSION ON THERAPEUTIC EFFICACY AND SAFETY. AUTHORS: AKEANONG WORAKITSITISATORN, DAVID S. LU, MIN WOO LEE, NAZANIN H. ASVADI, AMIN MOSHKSAR, ALEXANDER D. YUEN, JUSTIN MCWILLIAMS, STEVEN S. RAMAN . CITATION: EUROPEAN RADIOLOGY (2020) 30:1813¿1821; HTTPS://DOI.ORG/10.1007/S00330-019-06497-X . THIS STUDY AIMED TO EVALUATE THERAPEUTIC EFFICACY AND SAFETY OF PERCUTANEOUS THERMAL ABLATION OF SUBCAPSULAR HEPATOCELLULAR CARCINOMAS (HCCS) AFTER CATEGORIZING THEM INTO NONSURFACE CONTACT TUMORS AND SURFACE CONTACT TUMORS WITH OR WITHOUT SURFACE PROTRUSION OR EXOPHYTIC APPEARANCE. DURING JANUARY 2011- JUNE 2015, 290 PATIENTS WHO UNDERWENT RADIOFREQUENCY ABLATION (RFA) OR MICROWAVE ABLATION (MWA) AS THE FIRST TREATMENT WITH 474 HCCS AND 624 TOTAL ABLATION SESSIONS WERE INCLUDED IN THE STUDY. THERE WERE 208 MALES AND 82 FEMALES WITH A MEAN AGE OF 64.5+-10 (RANGE, 33-89) YEARS. ALL PROCEDURES WERE PERFORMED WITH COMBINED ULTRASOUND AND COMPUTED TOMOGRAPHY (CT) GUIDANCE. PERCUTANEOUS ABLATIONS WERE PERFORMED UNDER GENERAL ANESTHESIA. THERE WER

  Patient problems: Abscess; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Obstruction/Occlusion; Peritonitis; Pleural Effusion

  MAUDE report 12134543 ↗
• InjuryJul 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: COMPARING OUTCOMES FOR PATIENTS WITH CLINICAL T1B RENAL CELL CARCINOMA TREATED WITH EITHER PERCUTANEOUS MICROWAVE ABLATION OR SURGERY DANIEL D. SHAPIRO, SHANE A. WELLS, SARA L. BEST, SEAN P. HEDICAN, TIMOTHY J. ZIEMLEWICZ, MEGHAN G. LUBNER, JAMES LOUIS HINSHAW, FRED T. LEE JR, DAVID F. JARRARD, KYLE A. RICHARDS, TRACY M. DOWNS, GLENN O. ALLEN, STEPHEN Y. NAKADA, AND EDWIN JASON ABEL CITATION: UROLOGY 135, 2020 HTTPS://DOI.ORG/10.1016/J.UROLOGY.2019.09.024 THIS STUDY AIMS TO COMPARE PERIOPERATIVE AND ONCOLOGIC OUTCOMES FOR PATIENTS WITH CT1B RENAL CELL CARCINOMA (RCC) FOLLOWING TREATMENT WITH PERCUTANEOUS MICROWAVE ABLATION (MW), RADICAL NEPHRECTOMY (RN), OR PARTIAL NEPHRECTOMY (PN). BETWEEN JANUARY 2000 AND JUNE 2018 AT THE UNIVERSITY OF WISCONSIN,325 PATIENTS WITH RCC PATHOLOGIC DIAGNOSIS AND RADIOGRAPHIC 4-7 CM TUMOR DIAMETER WERE IDENTIFIED AND TREATED WITH EITHER PERCUTANEOUS MW, PN, OR RN .THERE WERE 40 PATIENTS IN MW COHORT (30 MALES, 10 FEMALES) AGE 69 (65-77 YEARS).ALL ABLATIONS WERE PERFORMED UNDER GENERAL ANESTHESIA AND IMMEDIATE POSTABLATION COMPUTED TOMOGRAPHY (CT) WAS PERFORMED TO ENSURE ADEQUATE TUMOR DESTRUCTION. ABLATIONS W

  Patient problems: Insufficient Information

  MAUDE report 12128095 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824 HTTPS://DOI.ORG/10.1007/S00261-020-02662-9 THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE (GE OPTIMA 580W, WAUKESHA, WI) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLATION

  Patient problems: Hematoma

  MAUDE report 12068388 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824 HTTPS://DOI.ORG/10.1007/S00261-020-02662-9 THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE (GE OPTIMA 580W, WAUKESHA, WI) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLATION

  Patient problems: Insufficient Information

  MAUDE report 12068336 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824 HTTPS://DOI.ORG/10.1007/S00261-020-02662-9 THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE (GE OPTIMA 580W, WAUKESHA, WI) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLATION

  Patient problems: Obstruction/Occlusion

  MAUDE report 12068247 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824 HTTPS://DOI.ORG/10.1007/S00261-020-02662-9 THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE (GE OPTIMA 580W, WAUKESHA, WI) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLATION

  Patient problems: Insufficient Information

  MAUDE report 12068158 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION. AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS. CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824. HTTPS://DOI.ORG/10.1007/S00261-020-02662-9. THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE ((B)(6)) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLATION PROCEDURES WERE PE

  Patient problems: Insufficient Information

  MAUDE report 12068125 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA. AFTER MICROWAVE ABLATION. AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS. CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824. HTTPS://DOI.ORG/10.1007/S00261-020-02662-9. THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE (GE OPTIMA 580W, WAUKESHA, WI) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLA

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12068045 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION. AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS. CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824 HTTPS://DOI.ORG/10.1007/S00261-020-02662-9. THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE (GE OPTIMA 580W, WAUKESHA, WI) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLATI

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12067983 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824 HTTPS://DOI.ORG/10.1007/S00261-020-02662-9 THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE (GE OPTIMA 580W, WAUKESHA, WI) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLATION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12067931 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION. AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS. CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824. HTTPS://DOI.ORG/10.1007/S00261-020-02662-9. THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE (GE OPTIMA 580W, WAUKESHA, WI) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLAT

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12067874 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824 HTTPS://DOI.ORG/10.1007/S00261-020-02662-9 THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE (GE OPTIMA 580W, WAUKESHA, WI) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLATION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12067824 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824 HTTPS://DOI.ORG/10.1007/S00261-020-02662-9 THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE (GE OPTIMA 580W, WAUKESHA, WI) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLATION

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12067776 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: CT AND MR IMAGING SURVEILLANCE OF STAGE 1 RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION. AUTHORS: KARLA A. WETLEY , E. JASON ABEL , LEO D. DREYFUSS , WEI HUANG , CHRIS L. BRACE , SHANE A. WELLS. CITATION CITE:ABDOMINAL RADIOLOGY (2020) 45:2810¿2824 HTTPS://DOI.ORG/10.1007/S00261-020-02662-9. THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE CT AND MR IMAGING FINDINGS AFTER MICROWAVE ABLATION OF CLINICAL STAGE 1 RENAL CELL CARCINOMA (RCC). THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS PERFORMED UNDER A WAIVER OF INFORMED CONSENT. 49 PATIENTS (38 M/11F, MEAN AGE 66 ± 9.0) WITH 52 CT1A RCC AND 19 PATIENTS (10M/9F, MEAN AGE 67 ± 9.7) WITH 19 CT1B RCC WERE TREATED WITH PERCUTANEOUS MICROWAVE ABLATION BETWEEN JANUARY 2012 AND JUNE 2014. THE SIZE AND VOLUME OF THE RCC AND ABLATION ZONE WERE MEASURED AND THE KIDNEY, ABLATION ZONES AND RETROPERITONEUM WERE ASSESSED AT IMMEDIATE POST-PROCEDURE CT AND SURVEILLANCE CT AND MRI. MICROWAVE ABLATION PROCEDURES WERE PERFORMED IN A CT SUITE (GE OPTIMA 580W, WAUKESHA, WI) WITH THE PATIENT UNDER GENERAL ANESTHESIA. ALL ABLATION PROCEDURES WERE PERFORMED IN A SINGLE SESSION WITH CURATIVE INTENT. THE MICROWAVE ABLATI

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12067759 ↗
• InjuryJun 25, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: COMPARISON OF RADIOFREQUENCY AND MICROWAVE ABLATION AND IDENTIFICATION OF RISK FACTORS FOR PRIMARY TREATMENT FAILURE AND LOCAL PROGRESSION. AUTHORS: JOSEPH L. MCDEVITTA, MICHAEL D. COLLARD, RYAN P. MURPHY, PATRICK D. SUTPHIN, ADAM C. YOPP, AMIT G. SINGAL, SANJEEVA P. KALVA CITATION: CLINICAL IMAGING 67 (2020) 146¿151. THE OBJECTIVES OF THIS RETROSPECTIVE REVIEW WERE TO COMPARE THE PRIMARY EFFICACY AND LOCAL PROGRESSION OF HEPATOCELLULAR CARCINOMA (HCC) TREATED WITH RADIOFREQUENCY ABLATION (RFA) AND MICROWAVE ABLATION (MWA) AND TO ASSESS THE IMPACT OF HCC SIZE, LOCATION, AND PROCEDURE RELATED FACTORS ON PRIMARY EFFICACY AND LOCAL TUMOR PROGRESSION. A TOTAL OF 110 UNIQUE HCC UNDERWENT THERMAL ABLATION PROCEDURES. 40 PATIENTS HAD MWA WITH 29 MALES AND 11 FEMALES. THERE MEAN AGE WAS 61.7 YEARS. THE IMPLANT USED WAS A 2.45 GHZ NEUWAVE CERTUS 140 MWA SYSTEM. (N=1) SEVERE ADVERSE EVENT WHICH WAS A CASE OF ARTERIAL INJURY THAT REQUIRED EMBOLIZATION. (N=1) MODERATE ADVERSE EVENT WHICH INCLUDED PNEUMOTHORAX REQUIRING PLACEMENT OF THORACOSTOMY TUBE. (N=1) MODERATE ADVERSE EVENT WHICH INCLUDED A THIRD DEGREE BURN FROM THE GROUNDING PAD. (N=3) MILD ADV

  Patient problems: Embolism/Embolus; Full thickness (Third Degree) Burn; Hematoma; Insufficient Information; Nausea; Pain; Pneumothorax

  MAUDE report 12067102 ↗