THUNDERBEAT 5 mm, 10 cm, Inline Grip TB-0510ICRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170308734), received between Sep 18, 2018 and Jul 30, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier, 1 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.

Recalls naming this device

1. Oct 22, 2025Class IIOpen, Classified

   Firm is initiating a removal due to continued reports of adverse events.

   Z-1382-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THE THUNDERBEAT'S TIP BROKE OFF DURING AN UNSPECIFIED THERAPEUTIC PANCREATIC PROCEDURE. THE EVENT RESULTED IN A DELAY OF THE PROCEDURE NO LONGER THAN 30 MINUTES. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22664775 ↗
• MalfunctionJul 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE TISSUE PAD OF THE ULTRASONIC SURGICAL DEVICE CAME OFF ON THE THIRD OUTPUT. IT DID NOT FALL OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC LIVER RESECTION PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690200 ↗
• MalfunctionJun 8, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC)WAS INFORMED BY THE CUSTOMER THAT DURING THE PROCEDURE USING THE SUBJECT DEVICE, THE FOLLOWING EVENT OCCURRED. THE PROBE WAS BROKEN OFF. THE CUSTOMER PRESUMED THAT IT WAS IN CONTACT WITH THE SPREADING CLAMPS IN USE ON THE THYROID GLAND. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11955958 ↗
• MalfunctionFeb 26, 2020Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING LIVER SURGERY, THE SUBJECT DEVICE WAS USED. THE TIP OF THE DEVICE FELL OFF INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9759686 ↗
• MalfunctionSep 18, 2018Failure to Align; Failure to Align

  TWO OF 2. OLYMPUS WAS INFORMED THAT DURING AN ANAL POLYP EXCISION PROCEDURE, THE JAWS OF THE DEVICE WERE MISALIGNED, CAUSING THE DEVICE TO NOT WORK AFTER A FEW SECONDS. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL BLEEDING, AND THE PATIENT WAS REPORTED TO BE DOING WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7887511 ↗
• MalfunctionSep 18, 2018Failure to Align; Failure to Align

  ONE (1) OF 2. OLYMPUS WAS INFORMED THAT DURING AN ANAL POLYP EXCISION PROCEDURE, THE JAWS OF THE DEVICE WERE MISALIGNED, CAUSING THE DEVICE TO NOT WORK AFTER A FEW SECONDS. THERE WAS NO REPORTED PATIENT INJURY OR ADDITIONAL BLEEDING, AND THE PATIENT WAS REPORTED TO BE DOING WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7887504 ↗