THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X TB-0535FCXRecalls & reported problems

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 04953170392207), received between Apr 18, 2019 and Oct 18, 2020 — classified as 1 injury, 148 malfunctions.

The most frequently reported specific device problem is “Break” (148 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 149 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2020Break; Break

  DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. IT WAS REPORTED THAT THE PLASTIC PROTECTION BEGAN TO MELT. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10694932 ↗
• MalfunctionOct 23, 2019Break; Break

  DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE OUTPUT SWITCH DID NOT WORK. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON OCTOBER 11, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD WAS SEVERELY WORN AND THE COATING FOR THE ELECTRIC INSULATION OF THE PROBE WAS 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 9229175 ↗
• MalfunctionOct 18, 2019Break; Break

  DURING A LAPAROSCOPIC HEPATIC LEFT LATERAL SEGMENTECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, AN UNSPECIFIED ERROR OCCURRED FREQUENTLY AND THE USER WAS UNABLE TO SEAL & CUT THE TISSUE PROPERLY WITH 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 WAS SEVERELY WORN AND THE COATING OF THE PROBE FOR ELECTRIC INSULATION 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 9206549 ↗
• MalfunctionOct 18, 2019Break; Break

  DURING A LAPAROSCOPIC PARTIAL HEPATECTOMY, THE SUBJECT DEVICE WAS USED. PROBE DAMAGE 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 TISSUE PAD WAS SEVERELY WORN AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND THE PROBE COATING MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9206316 ↗
• MalfunctionOct 15, 2019Break; Break

  DURING A LAPAROSCOPIC HEPATECTOMY, THE SUBJECT DEVICE WAS USED. AFTER TWO HOURS SINCE THE SURGERY BEGAN, THE USER FOUND THE TISSUE PAD OF THE SUBJECT DEVICE WAS WORN. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON OCTOBER 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 9195277 ↗
• MalfunctionOct 11, 2019Break; Break

  DURING A THORACOSCOPIC ASSISTED ESOPHAGECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, UNSPECIFIED SHORT CIRCUIT ERROR OCCURRED AND THE USER FOUND 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, 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 9177875 ↗
• MalfunctionOct 3, 2019Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING A LAPAROSCOPIC DISTAL GASTRECTOMY, THE SUBJECT DEVICE WAS USED. AFTER AN HOUR FROM THE BEGINNING OF THE USE, PROBE DAMAGE ERROR (U504) OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON SEPTEMBER 18, 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 9149639 ↗
• MalfunctionSep 25, 2019Break; Break

  DURING A LAPAROSCOPIC PARTIAL HEPATECTOMY, THE SUBJECT DEVICE WAS USED. THE PROBE OF THE SUBJECT DEVICE WAS BROKEN OFF INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE SUBJECT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9114762 ↗
• MalfunctionSep 25, 2019Break; Break

  DURING A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, THE SUBJECT DEVICE WAS USED. 4 HOURS AFTER THE START OF THE PROCEDURE, PROBE DAMAGE ERROR OCCURRED AND THE TISSUE PAD OF THE SUBJECT DEVICE WAS DAMAGED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON SEPTEMBER 5, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT 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 9114595 ↗
• MalfunctionSep 24, 2019Break; Break

  DURING A LAPAROSCOPIC PROCTECTOMY, THE SUBJECT DEVICE WAS USED. IT WAS REPORTED THAT THE SUBJECT DEVICE WAS WORN AND PARTIALLY SEPARATED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. OLYMPUS MEDICAL SYSTEM CORP. (OMSC) FOUND THAT THE TISSUE PAD OF THE SUBJECT DEVICE WAS NOT SEPARATED BUT SEVERELY WORN AND THE PROBE FOR THE ELECTRIC INSULATION WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD AND PARTIALLY MISSING PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9108304 ↗
• MalfunctionSep 19, 2019Break; Break

  DURING A PROCEDURE OF LOWER DIGESTIVE TRACT, THE SUBJECT DEVICE WAS USED. AFTER MORE THAN 2 HOURS SINCE THE SURGERY BEGAN, PROBE DAMAGE ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. ON (B)(6) 2019, 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 9085431 ↗
• MalfunctionSep 18, 2019Break; Break

  DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, PROBE DAMAGE ERROR AND SEAL & CUT SHORT CIRCUIT ERROR OCCURRED. THE TISSUE PAD WAS WORN. 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 9085092 ↗
• MalfunctionSep 18, 2019Break; Break

  DURING A HEPATECTOMY, TWO DEVICES WERE USED. PROBE DAMAGE ERRORS AND SEAL & CUT SHORT CIRCUIT ERRORS OCCURRED FREQUENTLY. THE TISSUE PAD OF THE SUBJECT DEVICE WAS WORN AND PARTIALLY SEPARATED. THE USER EXCHANGED THE FIRST DEVICE FOR THE SECOND DEVICE. PROBE DAMAGE ERRORS AND SEAL & CUT SHORT CIRCUIT ERRORS OCCURRED FREQUENTLY. THE TISSUE PAD OF THE SECOND DEVICE WAS WORN AND PARTIALLY SEPARATED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY WAS REPORTED. THIS IS THE REPORT REGARDING THE SEPARATED TISSUE PAD OF FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084917 ↗
• MalfunctionSep 17, 2019Break; Break

  DURING A LAPAROSCOPIC HYSTERECTOMY, TWO OF THE SUBJECT DEVICES WERE USED. IN THE PROCEDURE, THE TISSUE PAD OF THE FIRST DEVICE WAS WORN AND PROBE DAMAGE ERROR OCCURRED. IT WAS REPORTED THAT THE PROBE HAD CRACK. THE SECOND DEVICE WAS USED BUT THE TISSUE PAD WAS WORN AND PROBE DAMAGE ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE REPORT REGARDING THE SECOND DEVICE. ON SEPTEMBER 3, 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 OF THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9079973 ↗
• MalfunctionSep 17, 2019Break; Break

  DURING A SURGERY FOR A RECTUM, THE SUBJECT DEVICE WAS USED. THE TISSUE PAD OF THE SUBJECT DEVICE WAS WORN AND DAMAGED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON SEPTEMBER 5, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN, THE PROXIMAL SIDE OF TISSUE PAD WAS STUCK OUT AND 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 9074483 ↗
• MalfunctionSep 10, 2019Break; Break

  DURING A HEPATOBILIARY AND PANCREATIC PROCEDURE, THE SUBJECT DEVICE WAS USED. IN PROCEDURE, THE 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 PROBE WAS BROKEN OFF AND THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE PROBE AND THE MISSING OF THE PROBE COATING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8978563 ↗
• MalfunctionSep 9, 2019Break; Break

  DURING A GASTRECTOMY, THREE DEVICES WERE USED. AFTER ABOUT 2 HOURS SINCE THE SURGERY BEGAN, SEAL & CUT SHORT CIRCUIT ERROR OCCURRED. THE USER EXCHANGED IT WITH THE 2ND DEVICE AND CONTINUED THE PROCEDURE. HOWEVER, AFTER ABOUT ONE HOUR OF USE, SEAL & CUT SHORT CIRCUIT ERROR OCCURRED. IT WAS REPORTED THAT THE TISSUE PAD OF AT LEAST ONE OUT OF TWO DEVICES WAS SEVERELY WORN, AND THE METAL PART WAS EXPOSED. THE USER EXCHANGED 2ND DEVICE WITH THE 3RD DEVICE AND CONTINUED THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH 3RD DEVICE. THERE WAS NO PATIENT INJURY REPORTED. TWO DEVICES WERE RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WAS NO INFORMATION ABOUT THE ORDER OF THE DEVICE USE. OMSC FOUND THAT THE TISSUE PAD OF THE ONE OF TWO DEVICES WAS SEVERELY WORN, THE METAL PART AT THE DISTAL SIDE WAS EXPOSED AND THE PROXIMAL SIDE OF THE TISSUE PAD WAS STUCK OUT. THE COATING FOR ELECTRIC INSULATION OF THE PROBE WAS PARTIALLY MISSING. THE TISSUE PAD WAS WORN, BUT THE METAL PART WAS NOT EXPOSED ON THE SECOND DEVICE. THIS IS THE REPORT REGARDING THE SEVERELY WORN TISSUE PAD, THE PROTRUSION OF THE TISSUE PAD AND THE MISSING OF THE PROBE COATING OF THE ONE OF TWO DEVI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8978329 ↗
• MalfunctionSep 5, 2019Break; Break

  DURING A LAPAROSCOPIC DISTAL GASTRECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE SUBJECT DEVICE GAVE OFF SMOKE DURING OUTPUT AND THE TISSUE PAD WAS SEVERELY WORN FROM THE CENTER TO THE DISTAL END OF THE GRASPING SECTION. 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 WAS SEVERELY WORN AND THE COATING OF THE PROBE FOR ELECTRIC INSULATION 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 8967858 ↗
• MalfunctionSep 4, 2019Break; Break

  WE RECEIVED THE FOLLOWING REPORT. *DURING A LAPAROSCOPIC HEPATECTOMY, THE SUBJECT DEVICE WAS USED. SEAL & CUT SHORT CIRCUIT ERROR (U508) OCCURRED FREQUENTLY WHEN THE USER CHECKED THE DEVICE, THE TISSUE PAD OF THE DEVICE WAS WORN. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. IT WAS REPORTED THAT THE DEVICE WAS A LOWER PERFORMANCE FOR CUTTING THAN USUAL. ON (B)(6) 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 8959056 ↗
• MalfunctionSep 4, 2019Break; Break

  DURING A LAPAROSCOPIC GASTRECTOMY, THE SUBJECT DEVICE WAS USED. THE TISSUE PAD OF THE SUBJECT DEVICE WAS DETACHED WHEN THE USER CLEANED THE DISTAL END 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 THE FOLLOWING. THE TISSUE PAD OF THE SUBJECT DEVICE WAS SEVERELY WORN, AND THE TISSUE PAD WAS STUCK OUT FROM THE GRASPING SECTION. THE TISSUE PAD WAS NOT DETACHED. 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 8958907 ↗
• MalfunctionSep 3, 2019Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING A LAPAROSCOPIC HEPATECTOMY, TWO DEVICES WERE USED. TWO DEVICES WERE DAMAGED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE SECOND ONE OF TWO REPORTS. ON (B)(6) 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 8954696 ↗
• MalfunctionSep 3, 2019Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING A LAPAROSCOPIC HEPATECTOMY, TWO DEVICES WERE USED. TWO DEVICES WERE DAMAGED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE FIRST ONE OF TWO REPORTS. (B)(6) 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 8954684 ↗
• MalfunctionAug 29, 2019Break; Break

  DURING A LAPAROSCOPIC DISTAL GASTRECTOMY, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, PROBE DAMAGE ERROR (U504 ERROR) AND SEAL SHORT CIRCUIT ERROR (U511 ERROR) OCCURRED FREQUENTLY. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON AUGUST 9, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND 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 8948298 ↗
• MalfunctionAug 29, 2019Break; Break

  DURING A LAPAROSCOPIC HEPATIC LEFT LATERAL SEGMENTECTOMY, THE SUBJECT DEVICE WAS USED. THE USER WAS CUTTING THE LIVER PARENCHYMA WITH THE SUBJECT DEVICE UNDER AN INSUFFICIENT VISION AND THE TISSUE PAD WAS WORN. 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 WAS SEVERELY WORN AND THE COATING OF THE PROBE FOR ELECTRIC INSULATION 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 8948201 ↗
• MalfunctionAug 26, 2019Break; Break

  DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE SUBJECT DEVICE WAS USED. AFTER MORE THAN 2 HOURS SINCE THE SURGERY BEGAN, PROBE DAMAGE ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON AUGUST 20, 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 8929251 ↗