THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type SRecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name at least one THUNDERBEAT 5 mm,20 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
- 344
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 3
We found 2 models of THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 344 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2018 and Sep 1, 2026 — classified as 38 injuries, 306 malfunctions.
The most frequently reported specific device problem is “Break” (202 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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,20 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-1373-2026 · Root cause: Under Investigation by firm · names 2 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-1001-2025 · 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-0995-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S problems
Device problems
- Break202
- Detachment of Device or Device Component51
- Material Separation33
- Peeled/Delaminated31
- Fracture18
- Degraded15
- Naturally Worn7
- Thermal Decomposition of Device6
Patient problems
- No Clinical Signs, Symptoms or Conditions235
- No Consequences Or Impact To Patient99
- No Known Impact Or Consequence To Patient5
- Blood Loss1
- Burn(s)1
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S TB-0520FCSElectrosurgical, cutting & coagulation & accessories2 recalls179 reports
- THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type S TB-0520FCSElectrosurgical, cutting & coagulation & accessories2 recalls165 reports
Recent THUNDERBEAT 5 mm,20 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.
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 29, 2026Improper or Incorrect Procedure or Method
THE CUSTOMER RETURNED THE THUNDERBEAT TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE OLYMPUS SERVICE REPAIR TECHNICIAN INDICATED THAT A USE OF EXPIRED PRODUCT WAS FOUND. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331122 ↗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 ↗MalfunctionFeb 27, 2026Break; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474472 ↗MalfunctionFeb 5, 2026Break; Peeled/Delaminated; Detachment of Device or Device Component
IT WAS REPORTED THE THUNDERBEAT'S PROBE BROKE IMMEDIATELY AFTER IT WAS ACTIVATED DURING UNSPECIFIED USE. ADDITIONAL DETAILS WERE REQUESTED FROM THE CUSTOMER BUT THE INFORMATION WAS UNKNOWN. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24269295 ↗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 16, 2026Material Fragmentation; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DIGESTIVE LAPAROTOMY PROCEDURE, THE TIP OF THE ULTRASONIC SURGICAL DEVICE BROKE AND A FRAGMENT FELL INTO THE PATIENT¿S ABDOMINAL CAVITY. THE FRAGMENT WAS RETRIEVED WITH DISSECTING FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101270 ↗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 ↗MalfunctionJan 2, 2026Break
IT WAS REPORTED THAT THE THUNDERBEAT OPEN EXTENDED JAW BROKE DURING NORMAL USE. THE BURNING PART OF THE JAW TIP HAS PARTIALLY COME OFF. THERE WERE NO REPORTS OF PATIENTS¿ HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952211 ↗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 29, 2025Fracture; Fracture
IT WAS REPORTED THE THUNDERBEAT SURGICAL INSTRUMENT'S TIP WAS BROKEN OFF DURING A THERAPEUTIC PANCREATECTOMY. IT WAS NOT SPECIFIED WHERE FRAGMENTS FELL. THERE WAS NOT REPORTED PATIENT INJURY ATTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23919185 ↗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 ↗
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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