N/A (REF 30-401LITE)Recalls & reported problems
Stryker Sustainability Solutions, Inc. · MyoSure LITE Tissue Removal Device · Class 2
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327507119), received between Jun 28, 2022 and Sep 22, 2026 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Use of Device Problem” (4 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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem4
- Defective Device2
- Mechanical Jam2
- Dull, Blunt1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information2
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862567 ↗MalfunctionAug 26, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50459569 ↗MalfunctionJul 9, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25762030 ↗MalfunctionMay 27, 2026
WHEN PRESSING THE PEDAL TO STOP INITIATING THE DEVICE, THE DEVICE HAD A 3.5 SECOND DELAY IN STOPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25299701 ↗MalfunctionJan 8, 2026Mechanical Jam
IT WAS REPORTED THE DEVICE WAS PLUGGED IN AND DIDN'T WORK OFF THE SHELF. THE MACHINE READ, "DEVICE NOT FOUND." AS REPORTED, THEY REPLACED DEVICE WITH ANOTHER ONE OFF THE SHELF AND IT WORKED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THERE WAS EXTENDED PROCEDURE TIME REPORTED HOWEVER THE COMPLAINANT IS NOT AWARE OF THE DURATION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24011894 ↗MalfunctionAug 20, 2025Defective Device
MYOSURE LITE ON GENERATOR ERROR READ "MYOSURE DEVICE NOT FOUND - 01070001." DEVICE JAWS STUCK OPEN. DISCONNECTED, TURNED DEVICE ON AND OFF, BUT ERROR PERSISTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22849187 ↗MalfunctionAug 11, 2025Dull, Blunt; Mechanical Jam; Dull, Blunt; Mechanical Jam
IT WAS REPORTED THAT THE MYOSURE DEVICE WOULD NOT OPEN AND CLOSE. THE CASE WAS COMPLETED WITH ANOTHER REPROCESSED DEVICE. AS REPORTED, THE BLADE WAS STUCK IN A CLOSED POSITION. 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 22779285 ↗InjuryApr 2, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DEVICE FAILED DURING HYSTEROSCOPY, HAD TO BE REMOVED FROM STERILE FIELD, AND PROCEDURE WAS CONVERTED TO DILATION AND CURETTAGE. 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 19027935 ↗MalfunctionFeb 13, 2024
MYOSURE LITE DEVICE FAILURE DURING HYSTEROSCOPY. MYOSURE DEVICE WAS REMOVED FROM THE STERILE FIELD AND THE PROCEDURE CONVERTED TO DILATION AND CURETTAGE PER SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18704220 ↗MalfunctionNov 7, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THE DEVICE KEPT ROTATING AFTER FOOT CONTROL WAS RELEASED AND DID NOT STOP IN THE CORRECT POSITION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS ONLY MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18087289 ↗MalfunctionJun 28, 2022Defective Device
FACULTY SURGEON WHILE USING REPROCESSED MYOSURE LITE TISSUE REMOVAL DEVICE, INFORMED CIRCULATION NURSE THAT DEVICE WAS NOT WORKING.
Patient problems: Insufficient Information
MAUDE report 14842701 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.