SonoSurg Transducer SonoSurg-T2H-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170142628), received between Aug 2, 2022 and Jul 20, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

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 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THE SONOSURG TRANSDUCER WAS USED IN COMBINATION WITH THE SONOSURG SCISSORS WHEN THE DEVICE WAS NOT ABLE TO SEAL A BLOOD VESSEL WHEN OUTPUT WAS ACTIVATED. THE ISSUE OCCURRED DURING A LAPAROSCOPIC APPENDECTOMY. DURING THE SAME PROCEDURE, HEMOSTASIS WAS ACHIEVED USING BIPOLAR ENERGY WITH NO BLOOD TRANSFUSION BEING NECESSARY. AFTER HEMOSTASIS WAS ACHIEVED, THE ADIPOSE TISSUE WAS SEALED SUCCESSFULLY. THERE WERE NO REPORTS OF ADDITIONAL PATIENT IMPACT. RELATED PATIENT IDENTIFIERS: (B)(6) SONOSURG CURVED SCISSORS, HIGH FREQUENCY, WITH PISTOL GRIP; (B)(6) SONOSURG TRANSDUCER; (B)(6) ULTRASONIC SURGICAL SYSTEM SONOSURG. THIS REPORT IS FOR (B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17363269 ↗
• MalfunctionAug 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER ORIGINALLY REPORTED THAT THE PROBE ON HIS OLYMPUS SONOSURG TRANSDUCER BROKE WHILE WIPING IT OUTSIDE THE BODY CAVITY DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, IT WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY HEALTH HAZARD FOR THE PATIENT. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE AMPLITUDE VALUE HAD DEVIATED FROM THE STANDARD VALUE. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE INCONSISTENT VALUES NOTED DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146281 ↗