THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X TB-0520FCXRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04953170392238), received between Apr 24, 2019 and Nov 22, 2019 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2019Break; Break

  DURING A TOTAL GASTRECTOMY, THE SUBJECT DEVICE WAS USED. ABOUT 4 HOURS SINCE THE SURGERY BEGAN, THE TISSUE PAD OF THE SUBJECT DEVICE WAS WORN AND AN UNSPECIFIED ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON NOVEMBER 8, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9360330 ↗
• MalfunctionNov 21, 2019Break; Break

  DURING A DISTAL GASTRECTOMY, THE SUBJECT DEVICE WAS USED. IN THE LATTER HALF OF THE PROCEDURE, THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN AND U508 ERROR (SEAL & CUT SHORT CIRCUIT ERROR) OCCURRED FREQUENTLY. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. AS A RESULT OF EVALUATION FOR THE SUBJECT DEVICE, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9360030 ↗
• MalfunctionOct 15, 2019Break; Break

  DURING A HEPATIC SEGMENTECTOMY, THE SUBJECT DEVICE WAS USED. AFTER ONE HOUR USAGE, AN UNSPECIFIED ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON SEPTEMBER 26, 2019, OLYMPUS MEDICAL SYSTEMS FOUND THAT THE COATING FOR THE ELECTRIC INSULATION OF THE PROBE WAS MISSING. THIS IS THE REPORT REGARDING THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195235 ↗
• MalfunctionSep 24, 2019Break; Break

  DURING AN OPEN HEPATECTOMY, THE SUBJECT DEVICE WAS USED. AFTER ABOUT TWO HOURS SINCE THE SURGERY BEGAN, THE USER FELT DECREASE SEALING PERFORMANCE OF THE SUBJECT DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9109204 ↗
• MalfunctionSep 12, 2019Break; Break

  DURING A PANCREATICODUODENECTOMY, THE SUBJECT DEVICE WAS USED. THE SEALING PERFORMANCES OF THE SUBJECT DEVICE DETERIORATED AFTER ABOUT 2 HOURS OF USE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON SEPTEMBER 11, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9014679 ↗
• MalfunctionSep 6, 2019Break; Break

  DURING A PANCREATICODUODENECTOMY, THIS SUBJECT DEVICE WAS USED. SEAL & CUT SHORT CIRCUIT ERRORS FREQUENTLY OCCURRED. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND FOLLOWING. THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN. THE COATING FOR THE ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8968579 ↗
• MalfunctionSep 6, 2019Break; Break

  DURING A HEPATECTOMY, THIS SUBJECT DEVICE WAS USED. AFTER 2 HOURS AND A HALF SINCE THE SURGERY BEGAN, THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN. AN UNSPECIFIED ERROR OCCURRED. THE USER BECAME UNABLE TO USE THE SUBJECT DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8968413 ↗
• MalfunctionSep 1, 2019Break; Break

  DURING A PANCREATICODUODENECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, SEAL & CUT SHORT CIRCUIT ERROR (U508 ERROR) OCCURRED FREQUENTLY. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE MISSING COATING OF THE PROBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8953036 ↗
• MalfunctionAug 26, 2019Break; Break

  DURING A TOTAL GASTRECTOMY BY LAPAROTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE SEAL & CUT SHORT CIRCUIT ERROR FREQUENTLY OCCURRED. ALSO, THE TISSUE PAD OF THE SUBJECT DEVICE WAS WORN. THE USER UNABLE TO USE THE SUBJECT DEVICES. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON AUGUST 19, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8929088 ↗
• MalfunctionAug 23, 2019Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING A LAPAROSCOPIC HEPATECTOMY, THE SUBJECT DEVICE WAS USED. PROBE DAMAGE ERROR (U504) OCCURRED AND THE USER BECAME UNABLE TO USE THE SUBJECT DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON AUGUST 8, 2019, WE FOUND THE FOLLOWING. THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE MISSING COATING OF THE PROBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8924322 ↗
• MalfunctionAug 22, 2019Break; Break

  DURING A PANCREATICODUODENECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, AN UNSPECIFIED ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE MISSING COATING OF THE PROBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8924008 ↗
• MalfunctionAug 22, 2019Break; Break

  DURING AN OPEN SURGERY OF PARTIAL HEPATECTOMY, THREE THUNDERBEAT DEVICES WERE USED. WHEN THE FIRST THUNDERBEAT DEVICE WAS BEING USED, PROBE DAMAGE ERROR OCCURRED. ABOUT 3 HOURS AFTER THE START OF PROCEDURE, THE TISSUE PAD WAS SEVERELY WORN. THE USER EXCHANGED THE DEVICE TO THE SECOND THUNDERBEAT DEVICE AND PROBE DAMAGE ERROR OCCURRED. ABOUT 1 HOUR AFTER USE, THE TISSUE PAD WAS SEVERELY WORN. THE INTENDED PROCEDURE WAS COMPLETED WITH THE THIRD THUNDERBEAT DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD OF THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923984 ↗
• MalfunctionAug 21, 2019Break; Break

  DURING A COLECTOMY, THE SUBJECT DEVICE WAS USED. ULTRASONIC LEVEL ERROR OCCURRED. WHEN THE USER TOUCHED THE DISTAL END OF THE SUBJECT DEVICE, THE PROBE OF THE DEVICE 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 PROBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8913977 ↗
• MalfunctionAug 8, 2019Break; Break

  OLYMPUS WAS INFORMED THAT DURING A HEPATOBILIARY SURGERY, THE SUBJECT DEVICE WAS USED. AFTER APPROXIMATELY TWO HOURS SINCE THE SURGERY BEGAN, OPEN CIRCUIT ERROR AND PROBE DAMAGE ERROR OCCURRED, AND THEN THE USER BECAME UNABLE TO USE THE SUBJECT DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN, AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8876766 ↗
• MalfunctionAug 7, 2019Break; Break

  DURING A HEPATIC SEGMENTECTOMY BY LAPAROTOMY, THE SUBJECT DEVICE WAS USED. IN PROCEDURE, THE PROBE DAMAGE ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JULY 24, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN, AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8868205 ↗
• MalfunctionAug 6, 2019Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING AN OPEN HEPATECTOMY, THE SUBJECT DEVICE WAS USED. PROBE DAMAGE ERROR (U504) OCCURRED FREQUENTLY. WHEN THE USER CHECKED THE DEVICE, THE USER NOTICED THAT THE TISSUE PAD OF THE DEVICE WAS WORN. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON AUGUST 2, 2019, WE FOUND THAT THE FOLLOWING. THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN. THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8863177 ↗
• MalfunctionAug 5, 2019Break; Break

  DURING A HEPATECTOMY, THE SUBJECT DEVICE WAS USED. AFTER MORE THAN 30 MINUTES SINCE THE SURGERY BEGAN, THE TISSUE PAD OF THE SUBJECT DEVICE WAS DAMAGED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JULY 26, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD WAS SEVERELY WORN AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858679 ↗
• MalfunctionAug 4, 2019Break; Break

  DURING A HEPATECTOMY, THIS SUBJECT DEVICE WAS USED. AFTER ONE HOUR USAGE, PROBE DAMAGE ERROR (U504) OCCURRED. THE TISSUE PAD OF THE SUBJECT DEVICE WAS WORN. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON, (B)(6) 2019, THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING OF THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858490 ↗
• MalfunctionJul 30, 2019Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING AN OPEN TOTAL GASTRECTOMY, THE SUBJECT DEVICE WAS USED. IN THE MIDDLE OF THE PROCEDURE, SEAL & CUT SHORT CIRCUIT ERROR (U508) OCCURRED FREQUENTLY AND THE USER BECAME UNABLE TO USE THE DEVICE. IN THE PROCEDURE, SEAL SHORT CIRCUIT ERROR (U511) OCCURRED. THE TISSUE PAD OF THE DEVICE WAS WORN. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JULY 25, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THE FOLLOWING. THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN. THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844278 ↗
• MalfunctionJul 29, 2019Break; Break

  DURING A PANCREATICODUODENECTOMY, THE SUBJECT DEVICE WAS USED. SEAL SHORT CIRCUIT ERROR (U511) OCCURRED. THE USER CLEANED THE DISTAL END OF THE SUBJECT DEVICE, YET SHORT CIRCUIT ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JULY 16, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN, AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8835047 ↗
• MalfunctionJul 22, 2019Break; Break

  DURING A TOTAL PANCREATECTOMY, THE SUBJECT DEVICE WAS USED. THE SEAL & CUT SHORT CIRCUIT ERROR FREQUENTLY OCCURRED AFTER 2 HOURS OF USE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JULY 10, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN, AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8810409 ↗
• MalfunctionJul 19, 2019Break; Break

  DURING A PANCREATICODUODENECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, AN UNSPECIFIED ERROR OCCURRED AND THE USER WAS UNABLE TO USE THE SUBJECT DEVICE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JUNE 27, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD WAS SEVERELY WORN AND THE PROXIMAL SIDE OF THE TISSUE PAD WAS STUCK OUT. THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD, THE PROTRUSION OF THE TISSUE PAD, AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8806102 ↗
• MalfunctionJul 11, 2019Break; Break

  DURING A HEPATECTOMY, THE SUBJECT DEVICE WAS USED. AN ERROR OCCURRED. THE TISSUE PAD OF THE SUBJECT DEVICE WAS WORN AND SEPARATED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. AS A RESULT OF EVALUATION FOR THE SUBJECT DEVICE, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD OF THE SUBJECT DEVICE WAS NOT SEPARATED. THE TISSUE PAD WAS SEVERELY WORN AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8779481 ↗
• MalfunctionJul 2, 2019Break; Break

  DURING AN OPEN HYSTERECTOMY AND A LYMPH NODE DISSECTION, THE SUBJECT DEVICE WAS USED. THE SEAL & CUT SHORT CIRCUIT ERROR OCCURRED. THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN AND PARTIALLY SEPARATED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE SEPARATION OF THE TISSUE PAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8751887 ↗
• MalfunctionJun 30, 2019Break; Break

  DURING A PROCEDURE IN PYLORUS SIDE, THE SUBJECT DEVICE WAS USED. OPEN CIRCUIT ERROR OCCURRED. THE TISSUE PAD OF THE SUBJECT DEVICE WAS PARTIALLY SEPARATED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JUN 24, 2019, OLYMPUS MEDICAL SYSTEMS CORP. FOUND FOLLOWINGS. THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN. THE PROXIMAL SIDE OF TISSUE PAD WAS STUCK OUT. THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD, THE PROTRUSION OF THE TISSUE PAD, AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746921 ↗