N/A (REF 50-601XL)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327507140), received between Oct 27, 2022 and Jun 8, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026

  MYOSURE HANDPIECE BEGAN TO JERK AND MOVE BACK AND FORTH VIOLENTLY. THE RESIDENT HELD HER HAND STEADY AND FIRMLY TO KEEP ABSOLUTE CONTROL OF THE HANDPIECE. THE CIRCULATOR OPENED A 2ND MYOSURE HANDPIECE, WHICH DID THE SAME THING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428180 ↗
• MalfunctionMar 4, 2026Dull, Blunt

  IT WAS REPORTED THAT THE MYOSURE BLADE WAS STUCK IN THE OPEN POSITION FORM THE BEGINNING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514361 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT THE MYOSURE DEVICE WOULD NOT DISSECT TISSUE AND THE CASE WAS COMPLETED WITH AN OEM DEVICE. AS REPORTED, THE USER WAS TRYING TO GRAB SOMETHING OUTSIDE OF THE IFU PARAMETERS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22779350 ↗
• InjuryOct 27, 2022Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON HAD TO OPEN FIVE DIFFERENT MYOSURE DEVICES FOR A PROCEDURE BECAUSE THEY WERE NOT SHARP ENOUGH. THE SURGEON WAS UNABLE TO COMPLETE SURGERY BEFORE MAXING PATIENT FLUID DEFICIT OF 2500 ML NACL. THE SURGEON STATED ABOUT 70% OF THE LARGE UTERINE MYOMA WAS REMOVED, REQUIRING THE PATIENT TO RETURN FOR ANOTHER SURGERY TO COMPLETE THE REMOVAL OF MYOMA. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686133 ↗
• InjuryOct 27, 2022Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON HAD TO OPEN FIVE DIFFERENT MYOSURE DEVICES FOR A PROCEDURE BECAUSE THEY WERE NOT SHARP ENOUGH. THE SURGEON WAS UNABLE TO COMPLETE SURGERY BEFORE MAXING PATIENT FLUID DEFICIT OF 2500 ML NACL. THE SURGEON STATED ABOUT 70% OF THE LARGE UTERINE MYOMA WAS REMOVED, REQUIRING THE PATIENT TO RETURN FOR ANOTHER SURGERY TO COMPLETE THE REMOVAL OF MYOMA. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686028 ↗
• InjuryOct 27, 2022Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON HAD TO OPEN FIVE DIFFERENT MYOSURE DEVICES FOR A PROCEDURE BECAUSE THEY WERE NOT SHARP ENOUGH. THE SURGEON WAS UNABLE TO COMPLETE SURGERY BEFORE MAXING PATIENT FLUID DEFICIT OF 2500 ML NACL. THE SURGEON STATED ABOUT 70% OF THE LARGE UTERINE MYOMA WAS REMOVED, REQUIRING THE PATIENT TO RETURN FOR ANOTHER SURGERY TO COMPLETE THE REMOVAL OF MYOMA. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686024 ↗
• InjuryOct 27, 2022Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON HAD TO OPEN FIVE DIFFERENT MYOSURE DEVICES FOR A PROCEDURE BECAUSE THEY WERE NOT SHARP ENOUGH. THE SURGEON WAS UNABLE TO COMPLETE SURGERY BEFORE MAXING PATIENT FLUID DEFICIT OF 2500 ML NACL. THE SURGEON STATED ABOUT 70% OF THE LARGE UTERINE MYOMA WAS REMOVED, REQUIRING THE PATIENT TO RETURN FOR ANOTHER SURGERY TO COMPLETE THE REMOVAL OF MYOMA. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685990 ↗
• InjuryOct 27, 2022Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SURGEON HAD TO OPEN FIVE DIFFERENT MYOSURE DEVICES FOR A PROCEDURE BECAUSE THEY WERE NOT SHARP ENOUGH. THE SURGEON WAS UNABLE TO COMPLETE SURGERY BEFORE MAXING PATIENT FLUID DEFICIT OF 2500 ML NACL. THE SURGEON STATED ABOUT 70% OF THE LARGE UTERINE MYOMA WAS REMOVED, REQUIRING THE PATIENT TO RETURN FOR ANOTHER SURGERY TO COMPLETE THE REMOVAL OF MYOMA. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685978 ↗