THUNDERBEAT 5 mm, 20 cm, Inline Grip TB-0520ICRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170308710), received between Dec 27, 2018 and Apr 18, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (4 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, 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866380 ↗
• MalfunctionApr 18, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866258 ↗
• MalfunctionApr 18, 2025Peeled/Delaminated; Peeled/Delaminated

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865011 ↗
• MalfunctionMar 24, 2023Fracture; Material Separation; Fracture; Material Separation

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, THE THUNDERBEAT TISSUE PAD CAME OFF DURING SURGERY. THE UNSPECIFIED THERAPEUTIC PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORTED PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616280 ↗
• MalfunctionNov 10, 2022Break; Break

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, AT THE BEGINNING OF A THERAPEUTIC PROCEDURE FOR THYROID, ONE OF THE JAWS OF THE DEVICE BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW SIMILAR DEVICE. IT IS NOT KNOWN IF THERE WAS A DELAY IN THE COMPLETION. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE SURGEON IS A REGULAR USER OF THE DEVICE AND WAS SURPRISED BY THE FAILURE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15768481 ↗
• MalfunctionAug 19, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT DURING A THERAPEUTIC LAPAROTOMY PROCEDURE, THE TISSUE PAD WAS PEELING OFF. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE OF THE SAME MODEL. THERE WAS NO HEALTH HAZARD TO THE PATIENT. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262247 ↗
• MalfunctionFeb 1, 2022Break; Break

  AS REPORTED BY THE CUSTOMER FOR THIS EVENT, DURING AN UNKNOWN THERAPEUTIC PROCEDURE, THE GENERATOR SOUNDED AN ALARM FOR THE DEVICE. ATTEMPTS WERE MADE TO DISCONNECT AND RECONNECT THE DEVICE, BUT THE DEVICE WOULD NOT WORK. A JAW OF THE DEVICE THEN FELL INTO THE OPERATING SITE. THE BROKEN PIECE WAS RETRIEVED. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13414130 ↗
• MalfunctionMar 12, 2020Break; Break

  DURING AN OPEN RADICAL NEPHRECTOMY WITH INFERIOR VENA CAVA THROMBECTOMY, THE SUBJECT DEVICE WAS USED. AROUND FOUR TO FIVE HOURS AFTER THE START OF THE PROCEDURE, AN UNSPECIFIED ERROR OCCURRED. THE NURSE EXAMINED THE SUBJECT DEVICE OUTSIDE THE PATIENT AND CONFIRMED THAT IT WAS INTACT. THE SUBJECT DEVICE WAS CHECKED WITH THE GENERATOR AGAIN AND IT PASSED THE TEST. WHEN THE USER PUT THE SUBJECT DEVICE INSIDE THE INSTRUMENT POUCH, THE BOTTOM JAW BROKE OFF. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE BOTTOM JAW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9822473 ↗
• MalfunctionJul 29, 2019Melted; Melted

  SERVICE CENTER WAS INFORMED THAT DURING A DIAGNOSTIC, COAG, SIGMOID COLECTOMY PROCEDURE THE SILICON LAYER ON THE JAWS OF THE DEVICE MELTED. THE DEVICE AND ASSOCIATED EQUIPMENT WERE INSPECTED PRIOR TO USE AND NO ABNORMALITIES OBSERVED. IT WAS REPORTED THAT GENERATOR SETTING WAS 1-1 AND NO ERROR CODES DISPLAYED ON THE GENERATOR WHEN THE EVENT OCCURRED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8837082 ↗
• MalfunctionMay 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS WAS INFORMED THAT A SCHEDULED THERAPEUTIC COLONOSCOPY PROCEDURE WAS NEVER PERFORMED BECAUSE THE HAND-PIECE WAS FOUND TO HAVE THE TEFLON PAD HANGING OFF. THE HAND-PIECE WAS INSPECTED PRIOR TO USE AND THAT IS WHEN THE DAMAGE WAS NOTICED. THE DEVICE WAS NEVER USED ON THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8600307 ↗
• MalfunctionDec 27, 2018Break; Break

  DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE TISSUE PAD WAS BURNED. NO PATIENT INJURY WAS REPORTED. AS THE RESULT OF EVALUATION ON (B)(6) 2018, IT WAS FOUND THAT THE TISSUE PAD WAS SEVERELY WORN. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8201446 ↗