THUNDERBEAT 5 mm, 35 cm, Inline Grip TB-0535IC (UDI 04953170308697)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170308697), received between Mar 26, 2019 and Apr 30, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT THE GRASPING PART OF TWO ULTRASONIC SURGICAL DEVICES BROKE OFF. THE MOUTH WAS ALSO BROKEN OFF IN THE PACKAGING. CONSEQUENTLY, THERE WAS A 5-MINUTE DELAY TO THE LAPAROSCOPIC ANTERIOR RESECTION SURGERY TO GET A NEW DEVICE TWICE. THE CUSTOMER LATER CLARIFIED THAT THE PROBE OF THE OTHER ULTRASONIC SURGICAL DEVICE FELL INSIDE THE PATIENT AND WAS REMOVED USING FORCEPS, WHICH TOOK 1 MINUTE. THE SAME EXACT ISSUE REPORTEDLY HAPPENED FOR THE SUBJECT DEVICE. THERE WAS A 10-MINUTE DELAY TO THE THERAPEUTIC PROCEDURE WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, WHICH WAS THEN COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217201 ↗
• InjuryApr 30, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS INITIALLY REPORTED THAT THE GRASPING PART OF TWO ULTRASONIC SURGICAL DEVICES BROKE OFF. THE MOUTH WAS ALSO BROKEN OFF IN THE PACKAGING. CONSEQUENTLY, THERE WAS A 5-MINUTE DELAY TO THE LAPAROSCOPIC ANTERIOR RESECTION SURGERY TO GET A NEW DEVICE TWICE. THE CUSTOMER LATER CLARIFIED THAT THE PROBE OF THE SUBJECT DEVICE FELL INSIDE THE PATIENT AND WAS REMOVED USING FORCEPS, WHICH TOOK 1 MINUTE. THE SAME EXACT ISSUE REPORTEDLY HAPPENED FOR THE OTHER DEVICE. THERE WAS A 10-MINUTE DELAY TO THE THERAPEUTIC PROCEDURE WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, WHICH WAS THEN COMPLETED WITHOUT FURTHER INCIDENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217092 ↗
• MalfunctionFeb 26, 2021Break; Break

  DURING A LAPAROSCOPIC RADICAL HYSTERECTOMY, THE SUBJECT DEVICE WAS USED. AFTER 20 MINUTES SINCE THE SURGERY BEGAN, THE GENERATOR SHOWED AN ERROR IN THE PROBE. WHEN THE USER CHECKED THE SUBJECT DEVICE, THE PROBE WAS BROKEN OFF. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT WITHOUT DIFFICULTIES. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11383399 ↗
• MalfunctionMar 26, 2019Melted; Melted

  OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC LAPAROSCOPY PROCEDURE, THE TEFLON PAD FROM THE GRASPING SECTION OF THE DEVICE MELTED. NO DEVICE FRAGMENT FELL INTO THE PATIENT. THERE WAS NO METAL EXPOSED ON THE DEVICE JAW. THE GENERATOR SETTINGS WERE UNKNOWN AND NO ERROR MESSAGES WERE OBSERVED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONALLY, THE USER FACILITY REPORTED THAT THE DEVICE AND THE CONNECTION POINTS WERE INSPECTED PRIOR TO THE PROCEDURE WITH NO ANOMALIES FOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8454215 ↗