ULTRASONIC BIPOLAR GENERATOR USG-410Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170406881), received between May 27, 2022 and Nov 18, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN INTRODUCTION OF THE INSTRUMENT, THE ULTRASONIC BIPOLAR GENERATOR PROBE BROKE OFF BEFORE ITS ACTUAL USE. THE INTENDED THERAPEUTIC PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITH NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706481 ↗
• MalfunctionNov 11, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE GENERATOR HAD VARIOUS ERROR CODES DURING USE (U504, U508, U510, U511 & U601). THE DEVICE WAS USED IN COMBINATION WITH A THUNDERBEAT WHERE THE ACTIVE BRANCH BROKE AND FELL OFF INTO THE PATIENT'S ABDOMEN. IT WAS ALSO REPORTED THAT THE TRANSDUCER CABLES WERE NEW. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOTHING RECEIVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658134 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER USING THE ULTRASONIC GENERATOR FOR A THERAPEUTIC GYNECOLOGICAL LAPAROSCOPY THE PATIENT HAD A BURN SCAR ON HER NECK. IT WAS BELIEVED THAT SOMETHING METALLIC HAD COME INTO CONTACT WITH THE NECK. THE PATIENT WAS CURRENTLY BEING TREATED AT THE DERMATOLOGY DEPARTMENT OF THE FACILITY. THE PATIENT'S HOSPITALIZATION WAS NOT PROLONGED DUE TO THE INCIDENT. THERE WAS NO FURTHER IMPACT REPORTED.

  Patient problems: Burn(s)

  MAUDE report 20035056 ↗
• MalfunctionSep 28, 2022Output Problem; Output Problem

  IT WAS REPORTED THE (LOANER) DEVICE (USG-410) EXHIBITED AN ERROR MESSAGE OF "PLEASE RESTART THE GENERATOR" EACH TIME THE SURGEON ACTIVATED SEAL AND CUT. ACCORDING TO THE REPORTER, SEAL WAS ABSOLUTELY WORKING FINE. THE OLYMPUS REPRESENTATIVE WHO WAS PRESENT DURING THE THERAPEUTIC TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE TURNED THE DEVICE OFF SEVERAL TIMES HOWEVER, THE SURGEON WAS REPORTED LOST HIS PATIENCE WITH THE DISRUPTION AND CHANGED TRANSDUCER, CHANGED DEVICE TO A THIRD PARTY ETHICON (HARMONIC DEVICE). THE INTENDED PROCEDURE WAS COMPLETED USING THE THIRD PARTY DEVICE . THERE WAS A TEN (10) MINUTES DELAY IN THE PROCEDURE DUE TO THE CUSTOMER/OLYMPUS REPRESENTATIVE TRIED TO GET THE DEVICE (USG-410) TO WORK, HOWEVER, THE DELAY WAS REPORTED NOT CLINICALLY RELEVANT, PATIENT ACCORDING TO THE REPORTER IS ABSOLUTELY FINE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499252 ↗
• MalfunctionMay 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, APPROXIMATELY TWO (2) HOURS INTO A THERAPEUTIC HYSTERECTOMY PROCEDURE, THE ULTRASONIC BIPOLAR GENERATOR (USG-410) DISPLAYED TWO (2) PROBE DAMAGE ERROR CODES, U504 AND U601, AND STARTED BEEPING. THE THUNDERBEAT DEVICE WAS REMOVED FROM THE PATIENT AND THE PROBE JAWS WERE CLEANED WITH WET GAUZE, THE ELECTRODE WAS TESTED, THE CABLE WAS CHECKED AND IT WAS CONFIRMED THERE WAS NO CONTACT WITH METAL. AFTER PERFORMING TROUBLESHOOTING, THE CUSTOMER REPORTED THE SYSTEM PASSED TESTING. THE PHYSICIAN PROCEEDED TO INSERT THE THUNDERBEAT PROBE BACK INTO THE PATIENT¿S ABDOMEN. AT THE FIRST ACTIVATION OF THE THUNDERBEAT, THE JAWS BROKE INSIDE THE PATIENT. THE SURGEON IMMEDIATELY REMOVED THE THUNDERBEAT DEVICE AND THE BROKEN PIECE FROM THE ABDOMEN. THERE WAS NO PATIENT OR USER HARM REPORTED DUE TO THE EVENT. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME USG-410, BUT WITH A DIFFERENT THUNDERBEAT. IT IS UNKNOWN HOW THE BROKEN PIECE WAS RETRIEVED AND IF THERE WAS A PROCEDURAL DELAY. THIS EVENT INCLUDES TWO REPORTS: THIS REPORT IS FOR THE ULTRASONIC BIPOLAR GENERATOR, USG-410, S/N (B)(4), PATIENT IDENTIFIER (B)(6). THE THUNDERBEAT, TB-0535FCS, LOT KR14

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14524147 ↗