SonoSurg Generator SonoSurg-G2Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170319624), received between Jul 6, 2021 and Jul 7, 2021 — classified as 1 death, 1 injury.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "PREDICTIVE MODEL FOR POSTOPERATIVE PLEURAL EFFUSION AFTER HEPATECTOMY". THIS STUDY WAS CONDUCTED ON THE HEPATECTOMY FOR 325 PATIENTS. IN THE LITERATURE, IT WAS REPORTED AS FOLLOWS; THIS STUDY AIMS TO DEVELOP A PREDICTIVE MODEL FOR SEVERE POSTOPERATIVE PLEURAL EFFUSION AFTER HEPATECTOMY. THE CONSECUTIVE PATIENTS UNDERWENT HEPATECTOMY BETWEEN (B)(6) 2013 AND (B)(6) 2020. OF THE PATIENTS, 204 UNDERWENT LAPAROTOMIES AND 121 UNDERWENT LAPAROSCOPIC HEPATIC RESECTIONS. ALL PATIENTS WERE DIAGNOSED WITH 174 HEPATOCELLULAR CARCINOMAS (HCC), 82 COLORECTAL LIVER METASTASES (CRLM), 44 OF BILIARY CANCER, AND 25 OF OTHERS. HEPATIC PARENCHYMAL TRANSECTION WAS PERFORMED WITH THE SUBJECT DEVICE (CAVITRON ULTRASONIC SURGICAL ASPIRATOR (CUSA)) OR CLAMP CRUSH TECHNIQUE. THE COMPLICATIONS (CLAVIEN-DINDO 3 OR MORE) WERE 59 PATIENTS. THE COMPLICATIONS INCLUDED 22 SEVERE POSTOPERATIVE PLEURAL EFFUSION (SPOPE), 28 BILE LEAKAGE, 2 OPERATIVE DEATH. AND, 27 TRANSFUSIONS NEEDED INTRAOPERATIVE BLOOD LOSS WAS REPORTED. OMSC ASSUMES THAT SPOPES WERE NOT IDENTIFIED AS A RELATIONSHIP WITH THE SUBJECT DEVICE BECAUSE THERE IS NO INDIC

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12126126 ↗
• DeathJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUN 10, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "PREDICTIVE MODEL FOR POSTOPERATIVE PLEURAL EFFUSION AFTER HEPATECTOMY". THIS STUDY WAS CONDUCTED ON THE HEPATECTOMY FOR 325 PATIENTS. IN THE LITERATURE, IT WAS REPORTED AS FOLLOWS; STUDY AIMS TO DEVELOP A PREDICTIVE MODEL FOR SEVERE POSTOPERATIVE PLEURAL EFFUSION AFTER HEPATECTOMY. THE CONSECUTIVE PATIENTS UNDERWENT HEPATECTOMY BETWEEN JANUARY 2013 AND APRIL 2020. OF THE PATIENTS, 204 UNDERWENT LAPAROTOMIES AND 121 UNDERWENT LAPAROSCOPIC HEPATIC RESECTIONS. ALL PATIENTS WERE DIAGNOSED WITH 174 HEPATOCELLULAR CARCINOMAS (HCC), 82 COLORECTAL LIVER METASTASES (CRLM), 44 OF BILIARY CANCER, AND 25 OF OTHERS. HEPATIC PARENCHYMAL TRANSECTION WAS PERFORMED WITH THE SUBJECT DEVICE (CAVITRON ULTRASONIC SURGICAL ASPIRATOR (CUSA)) OR CLAMP CRUSH TECHNIQUE. THE COMPLICATIONS (CLAVIEN-DINDO 3 OR MORE) WERE 59 PATIENTS. THE COMPLICATIONS INCLUDED 22 SEVERE POSTOPERATIVE PLEURAL EFFUSION (SPOPE), 28 BILE LEAKAGE, 2 OPERATIVE DEATH. AND, 27 TRANSFUSIONS NEEDED INTRAOPERATIVE BLOOD LOSS WAS REPORTED. OMSC ASSUMES THAT SPOPES WERE NOT IDENTIFIED AS A RELATIONSHIP WITH THE SUBJECT DEVICE BECAUSE THERE IS NO INDICATIO

  Patient problems: Insufficient Information

  MAUDE report 12119831 ↗