N/A 00-7703-030-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00889024375468), received between Dec 9, 2020 and Jul 9, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (12 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Physical Resistance/Sticking

  Patient problems: Insufficient Information

  MAUDE report 25766161 ↗
• MalfunctionApr 23, 2026Failure to Cut

  IT WAS REPORTED THAT THE UNIT WAS NOT MESHING. THERE IS NO INFORMATION PROVIDED REGARDING THE TIMING OF THE EVENT OR IF THERE WAS ANY PATIENT INVOLVEMENT/HARM THAT MAY HAVE OCCURRED. DURING DEVICE EVALUATION IT WAS DISCOVERED THAT THE CUTTER FAILED THE SAMPLE MESH TEST DUE TO DAMAGE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24968525 ↗
• MalfunctionNov 21, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE MESHER PLATE WAS DAMAGED, AND THE CUTTERS WERE WORN DOWN. THIS CUTTER WAS FOUND TO FAIL THE CUT TEST AFTER FINAL INVESTIGATION. THERE WAS NO INFORMATION AVAILABLE REGARDING THE PATIENT IMPACT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23619478 ↗
• MalfunctionOct 23, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN TIME, ON AN UNKNOWN DATE, THE DEVICE WAS PRODUCING ROUGH AND NOT SMOOTH SKIN IN 3:1. IT IS UNKNOWN IF THERE WAS PATIENT INJURY, OR DELAY. DURING DEVICE EVALUATION, THE CUTTER FAILED THE TEST CUT. DUE DILIGENCE IS COMPLETED AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23372601 ↗
• MalfunctionSep 10, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY THE GRAFT GOT STUCK. PART OF THE GRAFT WAS ABLE TO BE UTILIZED TO FINISH THE CASE. THERE WAS A SMALL DELAY IN THE PROCEDURE BUT THERE WAS NO IMPACT TO THE PATIENT. AN ADDITIONAL UNPLANNED GRAFT WAS NOT NEEDED AS ONLY A SMALL PIECE OF THE TAKEN GRAFT WAS NOT SALVAGEABLE. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE CUTTER FAILED THE TEST CUT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019695 ↗
• MalfunctionJul 23, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE DEVICE WAS FOUND IN NEED OF REPAIR. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE CUTTER FAILED THE TEST CUT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576541 ↗
• MalfunctionJun 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING STERILIZATION, THE 3:1 ROLLER HAD A NICK ON IT. THE UNIT WASN¿T USED PRIOR TO STERILIZATION, SO DAMAGE MUST HAVE HAPPENED DURING RE-STERILIZATION AND NOT ON A PROCEDURE OR PATIENT. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION IT WAS DISCOVERED THAT THE CUTTER FAILED THE TEST CUT. DUE DILIGENCE IS COMPLETE, THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286605 ↗
• MalfunctionOct 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRODUCT WAS NOT IN USE AND WAS SENT IN FOR PREVENTATIVE MAINTENANCE. THERE WAS NO HARM OR INJURY TO PATIENT AS THERE WAS NO PATIENT INVOLVEMENT. THE MESHER WAS FOUND TO HAVE A DAMAGED COMB, AND CUTTER WAS NOTED TO BE DEFECTIVE. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT EVALUATION THE CUTTER FAILED THE TEST CUT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520269 ↗
• MalfunctionOct 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRODUCT WAS NOT IN USE AND WAS SENT IN FOR PREVENTATIVE MAINTENANCE. THERE WAS NO HARM OR INJURY TO PATIENT AS THERE WAS NO PATIENT INVOLVEMENT. THE MESHER WAS FOUND TO HAVE A DAMAGED COMB, AND CUTTER WAS NOTED TO BE DEFECTIVE. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT EVALUATION THE CUTTER FAILED THE TEST CUT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520191 ↗
• MalfunctionApr 30, 2024Material Deformation; Appropriate Device Problem Term/Code Not Available; Material Deformation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRODUCT WAS SENT IN FOR MAINTENANCE ONLY BUT REPAIR WAS NEEDED FOR DAMAGED ROLL AND RATCHET ISSUE. THERE WAS NO PATIENT INVOLVEMENT. DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER FAILED THE TEST CUT AS THE CUTTER WAS DAMAGED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211996 ↗
• MalfunctionNov 30, 2023Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE 2:1 ROLLER WAS TIGHT. WHEN THE DR. CHECKED THE INSTRUMENT, THEY NOTICED WITH GRILL WAS BENT. THEY TRIED TO UNBEND IT. THEY MANAGED TO USE IT FOR THE CASE BUT NOTICED THE RATCHETING HANDLE WAS ALSO NOT WORKING LIKE IT WAS SUPPOSED TO. EVENT OCCURRED PRIOR TO SURGERY. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE EVALUATION FOUND THE CUTTER FAILED THE TEST CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18241517 ↗
• MalfunctionNov 6, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE HAD A DAMAGED COMB. THERE WAS NO NOTED HARM OR DELAY IN THE PROCEDURE. DURING PRODUCT EVALUATION, THE CUTTER FAILED THE TEST CUT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18076627 ↗
• 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. UPON INVESTIGATION, THE CUTTERS FAILED THE CUT TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975710 ↗
• MalfunctionOct 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE WAS NOT FUNCTIONING PROPERLY. THERE WAS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL EVENT INFORMATION AVAILABLE. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER FAILED THE TEST CUT WITH AN INCOMPLETE CUT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876358 ↗
• MalfunctionSep 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING PREVENTIVE MAINTENANCE THERE WAS A LOCKING SYSTEM ISSUE. THERE WAS NO HARM OR DELAY REPORTED. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE, AND THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE. UPON INVESTIGATION, THE CUTTER FAILED THE TEST CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17842507 ↗
• MalfunctionSep 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE WAS NOT FUNCTIONING CORRECTLY. THERE WAS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION AVAILABLE. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER FAILED TESTING DUE TO AN INCOMPLETE CUT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697786 ↗
• MalfunctionAug 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THAT THE UNIT WAS FUNCTIONING INCORRECTLY. AFTER EVALUATION OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE CUTTER FAILED THE TEST CUT. THERE WERE NO HARM, INJURY OR DELAY ASSOCIATED WITH THE EVENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623982 ↗
• MalfunctionAug 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT BEFORE SURGERY, THE MESHER HAD A LOST SCREW FROM THE RATCHET HANDLE. THERE WAS NO PATIENT INVOLVEMENT. DURING EVALUATION THE CUTTER DID NOT PASS THE SAMPLE MESH TEST. DUE DILIGENCE IS COMPLETE, THERE IS NO FURTHER INFORMATION AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17622574 ↗
• 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 17611520 ↗
• MalfunctionJul 17, 2023Failure to Cut; Failure to Cut

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333573 ↗
• MalfunctionJun 28, 2023Failure to Cut; Failure to Cut

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216442 ↗
• MalfunctionJun 7, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING TESTING THE CUTTER DID NOT PASS THE CUT TEST. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, THERE IS NO FURTHER INFORMATION AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17082335 ↗
• MalfunctionFeb 15, 2023Failure to Cut; Failure to Cut

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379203 ↗
• MalfunctionFeb 6, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING MAINTENANCE, THE CUTTER FAILED THE TEST CUT ACCEPTANCE WITH AN INCOMPLETE CUT. NO ADVERSE EVENTS ASSOCIATED WITH THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303510 ↗
• MalfunctionSep 19, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING MAINTENANCE IT WAS NOTED THAT THE DAMAGED BOTTOM ROLL NEEDED AND A DAMAGED CUTTER NEEDED TO BE REPLACED. THERE WAS NO EVENT NOR PROCEDURE DELAY OR PATIENT INVOLVEMENT. EVALUATION LATER FOUND THAT THIS CUTTER FAILED THE CUT TEST. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445677 ↗