THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S TB-0520FCS (UDI 04953170383588)Recalls & reported problems
Olympus Medical Systems Corp. · THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S · Class 2
All models of THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus Thunderbeat is a hand instrument used in surgery to cut and seal tissue. Of its 163 adverse event reports, 155 are malfunctions and 8 are injuries, with no deaths. Many describe breaks and peeling pads, and one describes a broken clamp piece retrieved from a patient. Two open recalls name this device: one is a removal over repeated adverse event reports, and one covers probe tips that break or lose their pads.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 165
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 04953170383588), received between Aug 3, 2018 and Sep 1, 2026 — classified as 8 injuries, 157 malfunctions.
The most frequently reported specific device problem is “Break” (106 reports).
2 FDA recall records name this device's identifier, 2 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, 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.
Reports received per month
Recalls naming this device
- Oct 22, 2025Class IIOpen, Classified
Firm is initiating a removal due to continued reports of adverse events.
Z-1373-2026 · 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-0995-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Break106
- Peeled/Delaminated24
- Detachment of Device or Device Component19
- Degraded11
- Material Separation9
- Fracture7
- Naturally Worn5
- Electrical Shorting3
Patient problems
- No Clinical Signs, Symptoms or Conditions114
- No Consequences Or Impact To Patient50
- Foreign Body In Patient1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 165 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550841 ↗MalfunctionSep 1, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549484 ↗MalfunctionMay 20, 2026Naturally Worn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE TISSUE PAD WORN OUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25233525 ↗MalfunctionApr 20, 2026Detachment of Device or Device Component
IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S PROBE BROKE AT THE TOP AFTER COMPLETION OF A PROCEDURE. THERE WAS NO REPORT OF DEVICE FRAGMENTS FALLING WITHIN PATIENT ANATOMY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. MULTIPLE ATTEMPTS WERE MADE TO REQUEST ADDITIONAL INFORMATION BUT NO RESPONSE WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24932127 ↗MalfunctionJan 28, 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 24198846 ↗InjuryJan 13, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROTOMY PROCEDURE, THE ULTRASONIC SURGICAL DEVICE CLAMP (INSULATION COATING) BROKE. AN AUDIBLE ALERT SOUNDED AND A MESSAGE APPEARED ON THE GENERATOR ASKING FOR THE CLAMP TO BE CHANGED. THE PHYSICIAN NOTICED THIS IMMEDIATELY AND WAS ABLE TO RETRIEVE THE PIECE OF METAL FROM THE PATIENT'S ABDOMEN. THERE WERE NO FURTHER REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054782 ↗MalfunctionDec 30, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
NO NEW INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23923624 ↗MalfunctionDec 23, 2025Thermal Decomposition of Device; Thermal Decomposition of Device
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877797 ↗MalfunctionDec 22, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S, EXHIBITED TISSUE PAD FALLING OFF. NO PATIENTS WERE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865332 ↗MalfunctionDec 11, 2025Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT EXHIBITED THE TISSUE PAD WAS WORN AND THE PROBE WAS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23780280 ↗MalfunctionDec 8, 2025Fracture; Fracture
IT WAS REPORTED THE THUNDERBEAT'S ULTRASOUND PROBE WAS BROKEN DURING A THERAPEUTIC HEMIHEPATEKTOMIE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23745772 ↗MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S COATING WAS COMING OFF DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23745058 ↗InjuryNov 26, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660275 ↗InjuryNov 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED DURING A THERAPEUTIC LIVER RESECTION PROCEDURE, THE PROBE OF THE ULTRASONIC SURGICAL DEVICE BROKE. THE BROKEN PIECE OF THE PROBE WAS SAFELY REMOVED FROM THE PATIENT. THE ISSUE DID NOT AFFECT THE PATIENT. A DELAY OF GREATER THAN OR EQUAL TO 30 MINUTES OCCURRED, HOWEVER THE PROCEDURE CONTINUED SAFELY AND WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633499 ↗InjuryNov 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED DURING A THERAPEUTIC LIVER RESECTION PROCEDURE, THE PROBE OF THE ULTRASONIC SURGICAL DEVICE BROKE. THE BROKEN PIECE OF THE PROBE WAS SAFELY REMOVED FROM THE PATIENT. THE ISSUE DID NOT AFFECT THE PATIENT. A DELAY OF GREATER THAN OR EQUAL TO 30 MINUTES OCCURRED, HOWEVER THE PROCEDURE CONTINUED SAFELY AND WAS COMPLETED WITH A BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633487 ↗MalfunctionNov 19, 2025Break; Break
IT WAS REPORTED THE THUNDERBEAT DEVICE TIP IS BROKEN DURING A THERAPEUTIC MYOMECTOMY PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23598535 ↗MalfunctionNov 17, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE EVALUATION, THE THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S EXHIBITED PEELING OF THE PROBE COATING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23576595 ↗MalfunctionNov 10, 2025Degraded; Electrical Shorting; Naturally Worn; Degraded; Electrical Shorting; Naturally Worn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE TISSUE PAD WAS WORN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23512110 ↗MalfunctionNov 6, 2025Fracture; Fracture
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23492787 ↗MalfunctionOct 24, 2025Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC SURGICAL DEVICE EXHIBITED THE TISSUE PAD WAS WORN OUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23385654 ↗MalfunctionOct 23, 2025Degraded; Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE PAD WAS WORN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368821 ↗MalfunctionOct 20, 2025Break; Failure to Deliver Energy; Peeled/Delaminated; Electrical Shorting; Break; Failure to Deliver Energy; Peeled/Delaminated; Electrical Shorting
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE TISSUE PAD WAS WORN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334212 ↗MalfunctionAug 28, 2025Degraded; Naturally Worn; Degraded; Naturally Worn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE THUNDERBEAT EXHIBITED WEARING OF THE TISSUE PAD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911287 ↗MalfunctionAug 22, 2025Break; Break
IT WAS REPORTED THE THUNDERBEAT FRONT ACTUATED GRIP JAW DETACHED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22880031 ↗MalfunctionAug 8, 2025Crack; Flaked; Peeled/Delaminated; Crack; Flaked; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THAT THE SUBJECT DEVICE EXHIBITED CRACK OF THE PROBE AND PEELING OFF THE COATING OF THE PROBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22746462 ↗
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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 · each recall links to the FDA recall notice
- 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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