THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type SRecalls & reported problems across all models
Olympus Medical Systems Corp. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
5 open recalls name at least one THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 64
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 5
We found 3 models of THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Aug 27, 2018 and Jan 27, 2026 — classified as 9 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Break” (49 reports).
5 FDA recall records name at least one of these models by its device identifier, 5 still open.
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
THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 22, 2025Class IIOpen, Classified
Firm is initiating a removal due to continued reports of adverse events.
Z-1371-2026 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Nov 25, 2024Class IIOpen, Classified
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-0999-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 25, 2024Class IIOpen, Classified
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-0998-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Nov 25, 2024Class IIOpen, Classified
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Z-0994-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Sep 12, 2023Class IIOpen, Classified
Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery
Z-0109-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S problems
Device problems
- Break49
- Detachment of Device or Device Component7
- Activation Problem3
- Peeled/Delaminated3
- Appropriate Device Problem Term/Code Not Available2
- Power Problem2
- Activation, Positioning or Separation Problem1
- Degraded1
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- No Consequences Or Impact To Patient9
- Foreign Body In Patient3
- No Known Impact Or Consequence To Patient3
- Hemorrhage/Blood Loss/Bleeding1
THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S TB-0545FCSInstrument, ultrasonic surgical3 recalls33 reports
- THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type S TB-0545FCSElectrosurgical, cutting & coagulation & accessories3 recalls16 reports
- THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S TB-0545FCSInstrument, ultrasonic surgical2 recalls15 reports
Recent THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE TISSUE PAD IN THE GRASPING SECTION WAS WORN AWAY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24190417 ↗InjuryJan 15, 2026Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24087582 ↗MalfunctionDec 23, 2025Break; Break
THE CUSTOMER REPORTED THAT, EARLY ON IN A THERAPEUTIC COLORECTAL RESECTION PROCEDURE, THE PAD OF THEIR THUNDERBEAT DEVICE BECAME LOOSE AFTER SEAL ACTIVATION. THE CUSTOMER FINISHED THE PROCEDURE WITH A REPLACEMENT OLYMPUS DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23885048 ↗MalfunctionDec 8, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT TISSUE PAD HAD SPLIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744238 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THE ULTRASONIC PROBE BROKE IN HALF DURING A THERAPEUTIC GASTRIC BYPASS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425847 ↗MalfunctionJul 3, 2025Break; Break
IT WAS REPORTED THE THUNDERBEAT FRONT GRIP TYPE S PROBE BROKE DURING USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22396216 ↗InjuryOct 7, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT TWO ULTRASONIC SURGICAL DEVICE USED DURING A THERAPEUTIC CELIOSCOPY (DISSECTION AROUND A POLYPROPYLENE ELEMENT), HAD THE SCISSOR BROKE (LOST JAWS) IN THE PATIENT'S BELLY DURING ADHESIOLYSIS. AFTER THE SECOND BREAKAGE, A MONOPOLAR HOOK AND ENDOBAG WERE USED TO REMOVE THE BROKEN PIECES. THE FIRST DEVICE WAS USED FOR ABOUT 30 MINUTES AND THE SECOND ONE FOR ABOUT 10 MINUTES. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20385176 ↗InjuryOct 7, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT TWO ULTRASONIC SURGICAL DEVICES USED DURING A THERAPEUTIC CELIOSCOPY (DISSECTION AROUND A POLYPROPYLENE ELEMENT), HAD THE SCISSOR BROKE (LOST JAWS) IN THE PATIENT'S BELLY DURING ADHESIOLYSIS. AFTER THE SECOND BREAKAGE, A MONOPOLAR HOOK AND ENDOBAG WERE USED TO REMOVE THE BROKEN PIECES. THE FIRST DEVICE WAS USED FOR ABOUT 30 MINUTES AND THE SECOND ONE FOR ABOUT 10 MINUTES. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20385140 ↗InjurySep 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THE THUNDERBEAT JAW BROKE OFF DURING A THERAPEUTIC SLEEVE GASTRECTOMY PROCEDURE AN FELL INTO THE PATIENT CAVITY. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20130209 ↗MalfunctionJul 22, 2024Break; Break
DURING THE DEVICE EVALUATION, THE THUNDERBEAT FRONT-ACTUATED GRIP EXHIBITED THE PROBE BROKEN AT ITS DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19801796 ↗InjuryMar 11, 2024Break; Detachment of Device or Device Component; Thickening of Material; Break; Detachment of Device or Device Component; Thickening of Material
IT WAS REPORTED, THE THUNDERBEAT COAGULATES WITHOUT CUTTING, AND AFTER IT WARMS UP, IT BREAKS AFTER 20 MINUTES. THE ISSUE CAUSED AN ADDITIONAL 25-MINUTE PROCEDURAL TIME. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18882740 ↗InjuryNov 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS, THE THUNDERBEAT SCISSOR WAS BROKEN OFF. THE ISSUE WAS FOUND DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THE FALLEN PART WAS RECOVERED SUCCESSFULLY, NO PATIENTS OR USERS WERE HARMED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18115077 ↗MalfunctionNov 2, 2023Material Separation; Material Separation
THE CUSTOMER REPORTED TO OLYMPUS THAT THE ENERGY RELEASE OF THE THUNDERBEAT WAS NOT WORKING. UPON INSPECTION OF THE CUSTOMER¿S RETURNED DEVICE IT WAS OBSERVED, THE TISSUE PAD WAS FOUND WORN WITH METAL EXPOSED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18055127 ↗InjuryJun 9, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THERAPEUTIC LAPAROSCOPIC SURGERY, ONE OF THE TWO PROBES OF THIS ULTRASONIC SURGICAL DEVICE, BROKE AND FELL INTO THE PATIENT'S ABDOMEN. THE GENERATOR WENT INTO ALARM BECAUSE THE FORCEPS COULD NO LONGER FUNCTION. THE PIECE WAS IMMEDIATELY RECOVERED AND THE CLAMP ISOLATED. ADDITIONAL INFORMATION RECEIVED THAT THE OPERATING MODE WAS COAGULATION. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. NO PROCEDURE DELAY. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17100908 ↗InjuryJun 8, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A GASTRIC BYPASS PROCEDURE, THE JAW OF THIS ULTRASONIC SURGICAL DEVICE BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN OFF DEVICE WAS RETRIEVED FROM THE PATIENT, AS REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE, HOWEVER, UNSUCCESSFUL. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17092936 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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