Ultrasonic GeneratorRecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 1
- Injuries reported
- 11
- Recalls
- 0
We found 3 models of Ultrasonic Generator by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Sep 27, 2016 and May 1, 2025 — classified as 1 death, 11 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Break” (2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Ultrasonic Generator problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Break2
- Communication or Transmission Problem2
- Mechanical Problem2
- Activation Problem1
- Connection Problem1
- Device Displays Incorrect Message1
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Hemorrhage/Blood Loss/Bleeding4
- No Consequences Or Impact To Patient3
- Burn(s)2
- Abdominal Distention1
- Bowel Burn1
- Burn, Thermal1
- Nerve Damage1
Ultrasonic Generator models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ultrasonic Generator USG-400Instrument, ultrasonic surgical12 reports
- Ultrasonic Generator USG-400ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 death5 reports
- Ultrasonic Generator USG-400Instrument, ultrasonic surgical4 reports
Recent Ultrasonic Generator adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 1, 2025Communication or Transmission Problem; Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21945176 ↗InjuryMay 1, 2025Communication or Transmission Problem; Communication or Transmission Problem
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTION TO B2. B2 SHOULD HAVE HAD REQUIRED INTERVENTION CHECKED INSTEAD OF OTHER SERIOUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21945136 ↗MalfunctionNov 6, 2024No Device Output; No Device Output
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620477 ↗InjuryOct 14, 2024Output Problem; Output Problem
IT WAS REPORTED THAT DURING A LAPACOLLE SURGERY, AN OVERCURRENT ERROR U010 OCCURRED WHEN USING THE SUBJECT DEVICE. THE PROCEDURE AND PATIENT'S ANESTHESIA WERE EXTENDED BY 30 MINUTES TO DEAL WITH THE ERRORS AS IT OCCURRED MULTIPLE TIMES AND TO REPLACE THE TRANSDUCER. THE PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE. NO ADDITIONAL MEDICATION WAS ADMINISTERED, AND THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20446565 ↗MalfunctionMar 2, 2023Mechanical Problem; Mechanical Problem
CUSTOMER REPORTED WITH AN ISSUE OF "FALLING APART". NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16475689 ↗MalfunctionMar 2, 2023Mechanical Problem; Mechanical Problem
CUSTOMER REPORTED WITH AN ISSUE OF "FALLING APART". NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16475657 ↗MalfunctionFeb 10, 2023Material Integrity Problem; Material Integrity Problem
CUSTOMER CONFIRMED THERE WAS NO PATIENT OR USER INJURY DUE TO THE DAMAGED SCREEN. THEY WERE UNSURE WHEN THE SCREEN WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16358900 ↗MalfunctionJan 5, 2023Break; Energy Output Problem; Break; Energy Output Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING TOTAL THYROIDECTOMY PROCEDURE, THERE WAS A MALFUNCTION OF THE THUNDERBEAT AND THE SEALING WAS TOO SLOW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IN ADDITION, IT WAS REPORTED THAT THE SCREEN OF THE ULTRASOUND GENERATOR IS DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16109181 ↗InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OUTCOME OF TRANSORAL ENDOSCOPIC THYROIDECTOMY VESTIBULAR APPROACH (TOETVA) IN COMPARISON WITH OPEN THYROIDECTOMY FOR BENIGN THYROID NODULES" BY SADQ GHALEB KADEM, ET AL. ABSTRACT OPEN THYROIDECTOMY; IS THE GOLD STANDARD SURGICAL PROCEDURE FOR THYROID DISEASES, BUT THE INCISION SCAR IN THE ANTERIOR ASPECT OF THE NECK DUE TO THIS APPROACH CANNOT BE AVOIDED AND MAY RESULTS IN A PERMANENT COSMETIC DEFECT. THEREFORE, THERE IS A NEED TO IMPROVE POSTOPERATIVE QUALITY OF LIFE, INCLUDING COSMETICS. RECENTLY, TRANSORAL ENDOSCOPIC THYROIDECTOMY HAS BEEN DEVELOPED; IT IS A NATURAL ORIFICE THYROID SURGERY, MINIMALLY INVASIVE AND COMPLETELY SCAR FREE. THIS STUDY AIMED TO DESCRIBE THE OUTCOME, PATIENT¿S SATISFACTION, AND COMPLICATIONS AFTER HEMITHYROIDECTOMY FOR BENIGN THYROID NODULES BY TRANSORAL ENDOSCOPIC VESTIBULAR APPROACH IN COMPARISON WITH OPEN APPROACH. THIS STUDY WAS CONDUCTED IN (B)(6), (B)(6) FROM AUGUST 2017 TO JUNE 2019 AND WAS APPROVED BY A LOCAL ETHICAL COMMITTEE. FIFTY PATIENTS WITH BENIGN THYROID NODULES WHO ARE CANDIDATE FOR HEMITHYROIDECTOMY WERE INCLUDED IN THE STUDY; THEY WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE METHOD FO
Patient problems: Hemorrhage/Blood Loss/Bleeding; Nerve Damage
MAUDE report 14015263 ↗InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: THE INTENDED PROCEDURE WAS A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A PROCEDURAL DELAY. IT IS UNKNOWN IF THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE. THE SMALL BOWEL THERMAL INJURY WAS OVERSEWN WITH THREE LEMBERT SUTURES.
Patient problems: Burn(s)
MAUDE report 13498574 ↗InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem
THE CUSTOMER RETURNED THE SUBJECT DEVICE FOR SERVICE AND INFORMED OLYMPUS THE PATIENT EXPERIENCED A 3MM SEROSAL THERMAL INJURY TO THE SMALL BOWEL. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION ARE IN PROGRESS.
Patient problems: Unspecified Tissue Injury
MAUDE report 13498487 ↗InjurySep 29, 2021Connection Problem; Connection Problem
THE CUSTOMER REPORTED TO OLYMPUS THE ULTRASONIC GENERATOR DISPLAYED AN INCORRECT CONNECTION MESSAGE DURING AN UNKNOWN PROCEDURE. THE CUSTOMER STATED THE PATIENT WAS BLEEDING WHILE ON THE EXAM TABLE. THE AMOUNT OF BLOOD LOSS THE PATIENT SUSTAINED IS UNKNOWN. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE IN ANOTHER PROCEDURE ROOM. THE PATIENT DID NOT EXPERIENCE FURTHER BLOOD LOSS AND RECOVERED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12548507 ↗InjurySep 29, 2021Device Displays Incorrect Message
THE CUSTOMER REPORTED TO OLYMPUS THE ULTRASONIC GENERATOR DISPLAYED AN INCORRECT CONNECTION MESSAGE DURING AN UNKNOWN PROCEDURE. THE CUSTOMER STATED THE PATIENT WAS BLEEDING WHILE ON THE EXAM TABLE. THE AMOUNT OF BLOOD LOSS THE PATIENT SUSTAINED IS UNKNOWN. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE IN ANOTHER PROCEDURE ROOM. THE PATIENT DID NOT EXPERIENCE FURTHER BLOOD LOSS AND RECOVERED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12548492 ↗DeathAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A PANCREATICODUODENECTOMY USING THE SUBJECT DEVICE THE FOLLOWING EVENT OCCURRED. AN UNSPECIFIED ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. ON (B)(6) 2021, WE RECEIVED THE FOLLOWING COMMENT FROM THE DOCTOR. THE DEVICE WAS EASY TO SCAB DURING USE, WHICH CAUSED THE BLOOD VESSELS TO CLOT AT THAT TIME, AND THEN THE SCAB FELL OFF AND THE PATIENT OCCURRED ABDOMINAL(SMALL MESENTERIC BLOOD VESSELS) OCCURRED BLEEDING. IT WILL BE PERFORMED SURGERY AGAIN TO STOP THE BLEEDING. THE PATIENT DIED FINALLY OF EXCESSIVE POSTOPERATIVE BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12311392 ↗MalfunctionMar 26, 2020Activation Problem; Activation Problem
IT WAS REPORTED THAT DURING A THERAPEUTIC PROCEDURE AN ERROR MESSAGE OF ¿SHORT CIRCUIT ERROR¿ OCCURRED. THE DEVICE ACCORDING TO THE USER WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE OBSERVED. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INJURY OR HARM REPORTED DUE TO THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9884914 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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