SonoSurg Generator Set SonoSurg-G2 SetRecalls & reported problems
Olympus Medical Systems Corp. · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170170898), received between Jul 20, 2023 and Jul 20, 2023 — classified as 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 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 ULTRASONIC SURGICAL SYSTEM SONOSURG GENERATOR 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 17363709 ↗
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- Harmonic ACE HARH23Ethicon Endo-Surgery, LLC · Instrument, ultrasonic surgical935 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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