N/A (REF 10-401FC)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07613327507133), received between Sep 1, 2023 and Sep 29, 2026 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940822 ↗
• MalfunctionSep 23, 2026Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862955 ↗
• InjuryMay 6, 2026Material Separation

  IT WAS REPORTED DURING THE CASE, THE BLADE CAME OFF AND WERE UNSURE IF THE PIECE WAS IN THE PATIENT OR IN THE SHAFT OF THE DEVICE. IT WAS FURTHER REPORTED AN XRAY WAS PERFORMED AND THERE WAS NO BROKEN PIECE FOUND. THERE WAS NO REPORTED PATIENT INJURY AND EXTENDED PROCEDURE TIME REPORTED WAS THEY NEEDED TO OPEN AN XL DEVICE AND CHANGE THE SCOPE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25106901 ↗
• MalfunctionDec 19, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MYOSURE OPERATED AS NORMAL AT THE BEGINNING OF THE CASE. THE PATIENT WAS HIGH IN THE BED AND THE DOCTOR HAD A HARD TIME VISUALIZING, SO THEY HAD TO STOP THE PROCEDURE AND MOVE THE PATIENT DOWN. UPON RESUMING THE END OF THE PROCEDURE, THE STAFF AND THE DOCTOR SAID THERE WAS ¿GLITTER¿/METAL SHAVINGS SWIRLING AROUND ON THE CAMERA AND THAT IT WAS FROM THE MYOSURE DEVICE." THE CIRCULATOR STATED THEY BELIEVED THE METAL SHAVINGS WERE FLUSHED OUT FROM THE FLUID MANAGEMENT SYSTEM. IT COULD NOT BE CONFIRMED SINCE THE SHAVINGS WERE SO SMALL. NO OTHER ACTION WAS TAKEN BY THE SURGEON OR THE TEAM FOR THE METAL SHAVINGS. 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 23857701 ↗
• MalfunctionDec 2, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MYOSURE DEVICE WAS DEFECTIVE. THE SURGEON REPORTED THAT THE MYOSURE REACH WAS SHEARING OFF METAL INSIDE THE PATIENT DURING USE. 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 23698748 ↗
• MalfunctionSep 24, 2025Failure to Cycle; Material Separation; Material Deformation; Failure to Cycle; Material Separation; Material Deformation

  IT WAS REPORTED THAT THE MYOSURE REACH WIRES AND CONNECTION FROM THE CORD TO THE HANDPIECE DISCONNECTED AND THE WIRES WERE EXPOSED. IT WAS DISCOVERED WHEN PLUGGED INTO THE FLUENT MANAGEMENT MACHINE AND WAS NOT USED ON THE PATIENT. AS REPORTED, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 23139871 ↗
• MalfunctionAug 20, 2025Mechanical Problem; Decrease in Pressure; Device Displays Incorrect Message

  MYOSURE REACH ERROR "EXCESSIVE TORQUE DETECTED, REDUCE PRESSURE ON DEVICE, TAP FOOT PEDAL TO CONTINUE - (B)(4)." DEVICE WOULD NOT RELEASE FROM MACHINE. NEEDED TO OBTAIN NEW MACHINE AND HANDPIECE.

  Patient problems: Insufficient Information

  MAUDE report 22849167 ↗
• InjuryJul 29, 2025Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THE MYOSURE WAS BEING USED AN GAVE AN ERROR MESSAGE OF "TOO MUCH TORQUE PRESS MEDAL" AND THE PEDAL WOULD NOT OPERATE. WHEN THE INSTRUMENT WAS PULLED OUT, IT LOOKED LIKE THE JAW WOULD NOT OPEN. THE SURGEON "DOESN'T THINK THE PATIENT HAD ANY HARM" BUT THE UTERUS WAS PERFORATED. AS REPORTED, THE PROCEDURE WAS CONVERTED TO A DIAGNOSTIC LAPAROSCOPY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO OTHER INFORMATION WAS PROVIDED REGARDING MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 22642731 ↗
• MalfunctionJun 30, 2025Mechanical Problem; Difficult to Open or Close

  MYOSURE WAS BEING USED GAVE AN ERROR MESSAGE OF "TOO MUCH TORQUE PRESS PEDAL", PEDAL WOULDN'T OPERATE. WHEN PULLED INSTRUMENT OUT LOOKED LIKE JAW WOULDN'T OPEN. SURGEON "DOESN'T THINK THE PATIENT HAD ANY HARM" BUT THE UTERUS WAS PERFORATED. THE PROCEDURE WAS CONVERTED TO A DIAGNOSTIC LAPAROSCOPY. MANUFACTURER RESPONSE FOR HYSTEROSCOPE (AND ACCESSORIES), N/A (PER SITE REPORTER).

  Patient problems: Uterine Perforation

  MAUDE report 22352630 ↗
• MalfunctionJun 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE MYOSURE WOULD NOT TURN ON/GIVE POWER. THE SYSTEM WAS REBOOTED AND STILL DID NOT WORK. AS REPORTED, OEM WAS PULLED AND WORKED FINE ON THE SAME GENERATOR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TEN MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332175 ↗
• InjuryJun 19, 2025Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THERE WAS A FAULTY REPROCESSED MYOSURE HANDPIECE AND THE SURGEON WAS NOT HAPPY WITH THE DEVICE. ACCORDING TO THE SURGEON, IT IMPACTED THE PATIENT'S CARE AND THE PATIENT SCHEDULED FOR OUTPATIENT SURGERY HAD TO STAY THE NIGHT. THERE WERE NO DETAILS AVAILABLE ON WHY THE PATIENT WAS HAD TO THE STAY THE NIGHT. AS REPORTED, THE MYOSURE DEVICE WAS NOT CUTTING WELL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294301 ↗
• InjuryJun 19, 2025Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THERE WAS A FAULTY REPROCESSED MYOSURE HANDPIECE AND THE SURGEON WAS NOT HAPPY WITH THE DEVICE. ACCORDING TO THE SURGEON, IT IMPACTED THE PATIENT'S CARE AND THE PATIENT SCHEDULED FOR OUTPATIENT SURGERY HAD TO STAY THE NIGHT. THERE WERE NO DETAILS AVAILABLE ON WHY THE PATIENT HAD TO THE STAY THE NIGHT. AS REPORTED, THE MYOSURE DEVICE WAS NOT CUTTING WELL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290112 ↗
• MalfunctionMay 23, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A FAILURE OF THE MYOSURE ONCE THE SURGEON STARTED TO USE THE DEVICE. AS REPORTED, IT DID NOT WORK AFTER MULTIPLE TRIES. THE DEVICE WAS REPLACED WITH AN OEM DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES TO GET OEM DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080101 ↗
• MalfunctionApr 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE MYOSURE DEVICE WOULD NOT ENGAGE THE BLADE. 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 21912614 ↗
• MalfunctionApr 3, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE MYOSURE DEVICE LOCKED UP. AS REPORTED, THE DEVICE WAS REPLACED WITH A STRYKER MYOSURE LITE. 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 21767098 ↗
• MalfunctionApr 3, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE MYOSURE CORD WOULD JUMP, ALMOST LIKE A SHORT IN THE WIRING AND THEN THE EQUIPMENT WOULD SHUT OFF. 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 21763520 ↗
• MalfunctionMar 13, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE MYOSURE DEVICE IS NOT CUTTING AND MAKING GRINDING NOISE DURING SURGICAL PROCEDURE. DEVICE WAS REPLACED. 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 21599452 ↗
• MalfunctionFeb 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE MYOSURE DEVICE WAS NOT CUTTING. AS REPORTED, IT WAS REPLACED WITH ANOTHER STRYKER DEVICE AND WORKED FINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE EXTENDED PROCEDURE TIME REPORTED WAS FIVE MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313255 ↗
• MalfunctionJan 14, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE MYOSURE DEVICE SOUNDED LIKE GRINDING METAL, WAS NOT TURNING PROPERLY, AND WAS DIFFICULT TO REMOVE FROM THE MACHINE. 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 21151833 ↗
• MalfunctionOct 3, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT A MYOSURE DEVICE WAS JUMPING AND READING (REVVING) UP THE TORQUE. 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 20362248 ↗
• MalfunctionJun 1, 2024No Device Output; No Device Output

  IT WAS REPORTED THAT WHEN THE MYOSURE WAS PLUGGED IN AND ACTIVATED, THE SHAVER PART STARTED AND THEN STOPPED WORKING ALMOST IMMEDIATELY AFTER IT STARTED. IT WOULD TURN ON AND OFF A COUPLE TIMES, THEN NOT WORK AT ALL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS THREE MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19442097 ↗
• MalfunctionMay 16, 2024Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  IT WAS REPORTED THE DEVICE BLADES FAILED TO ACTUATE. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19336084 ↗
• InjuryApr 22, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DEVICE WOULD NOT WORK CONSISTENTLY AND PREVENTED THE DOCTOR FROM PERFORMING SURGERY AS PLANNED. HAD TO USE ANOTHER DEVICE AND DIFFERENT PIECE OF EQUIPMENT. COMPLAINANT NOT AWARE OF ANY OTHER PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160615 ↗
• InjuryApr 22, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DEVICE WOULD NOT WORK CONSISTENTLY AND PREVENTED THE DOCTOR FROM PERFORMING SURGERY AS PLANNED. HAD TO USE ANOTHER DEVICE AND DIFFERENT PIECE OF EQUIPMENT. DEVICE CABLE HAD TO BE PLIED OUT OF FLUENT MANAGEMENT SYSTEM. COMPLAINANT NOT AWARE OF ANY OTHER PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160613 ↗
• InjuryNov 7, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE DEVICE WAS COMPLETED WITH DILATION AND CURETTAGE (D&C) BECAUSE THE COMPLAINT DEVICE ACTIVATED AND FIRED BUT THEN FROZE. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE EXTENDED PROCEDURE TIME REPORTED WAS FIVE MINUTES TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18086846 ↗