N/A 00-7703-010-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024375437), received between Jan 12, 2021 and Aug 4, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50132548 ↗
• MalfunctionJan 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE DEVICE WAS IN NEED OF REPAIR FOR AN UNKNOWN REASON. DURING PRODUCT EVALUATION, IT WAS DISCOVERED THAT THE CUTTER FAILED THE SAMPLE MESH TEST DUE TO AN INCOMPLETE CUT. THERE WAS NO NOTE OF PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277759 ↗
• MalfunctionDec 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE DEVICE WAS SENT IN FOR PREVENTATIVE MAINTENANCE ORIGINALLY AND FOUND TO BE NEEDING REPAIRED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. DURING DEVICE EVALUATION THE CUTTER FAILED THE SAMPLE MESH TEST DUE TO AN INCOMPLETE MESH. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915785 ↗
• MalfunctionOct 20, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE HANDLE WAS NOT RATCHETING AND ITS LOOSENING GRUB SCREW IN THE HANDLE. THERE WAS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION. AT PRODUCT EVALUATION IT WAS NOTED THAT THIS DEVICE WAS FAILED THE TEST CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975628 ↗
• MalfunctionOct 4, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING UNKNOWN TIMING THE PRODUCT WAS FOUND TO BE DAMAGED. THERE WAS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE; NO ADDITIONAL INFORMATION. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER FAILED THE SAMPLE MESH TEST DUE TO AN INCOMPLETE MESH. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17872702 ↗
• MalfunctionAug 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT OUTSIDE OF SURGERY ON AN UNKNOWN DATE THE HANDLE JAMMED ON MESHER. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. AT EVALUATION IT WAS FOUND THAT THE CUTTERS FAILED THE TEST CUT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611507 ↗
• MalfunctionJul 28, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT PRIOR TO SURGERY THE MESHER GRATE IS DAMAGED, SO THE DEVICE DOES NOT WORK. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. AT INVESTIGATION THE CUTTER SENT IN WITH THE MESHER FAILED THE TEST CUT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414951 ↗
• MalfunctionJan 11, 2023Mechanical Problem; Calibration Problem; Mechanical Problem; Calibration Problem

  IT WAS REPORTED THAT THE DEVICE WAS HAVING ISSUES AND NEEDS TESTED AND CALIBRATED. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER FAILED THE TEST MESH WITH AN INCOMPLETE CUT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16139345 ↗
• MalfunctionJan 11, 2023Mechanical Problem; Calibration Problem; Mechanical Problem; Calibration Problem

  IT WAS REPORTED THAT THE DEVICE WAS HAVING ISSUES AND NEEDS TESTED AND CALIBRATED. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER FAILED THE TEST MESH WITH AN INCOMPLETE CUT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137809 ↗
• MalfunctionJan 11, 2023Mechanical Problem; Calibration Problem; Mechanical Problem; Calibration Problem

  IT WAS REPORTED THAT THE DEVICE WAS HAVING ISSUES AND NEEDS TESTED AND CALIBRATED. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER FAILED THE TEST MESH WITH AN INCOMPLETE CUT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137788 ↗
• MalfunctionDec 1, 2022Failure to Cut; Failure to Cut

  NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15900835 ↗
• MalfunctionAug 18, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE SKIN WASN'T MESHED CORRECTLY WHILE USING THE DAMAGED 1:5 CUTTER. IT OCCURRED DURING TESTING. INVESTIGATION FOUND THE CUTTER DID NOT PASS THE CUT TEST. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337837 ↗
• MalfunctionJan 12, 2021Failure to Cut; Failure to Cut

  DEVICE DRAGGING SKIN DURING SURGERY. REPORTED NO INJURY TO PATIENT. THERE WAS NO ADVERSE EVENT REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11154220 ↗