N/A 00-7703-020-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 00889024375451), received between Dec 7, 2020 and Sep 22, 2026 — classified as 103 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (76 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 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Failure to Cut

  Patient problems: Insufficient Information

  MAUDE report 50860630 ↗
• MalfunctionApr 28, 2026Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN TIME, THE DEVICE HAD A DAMAGE BLADE COMB. IT IS UNKNOWN IF THERE WAS PATIENT INJURY, OR DELAY. DURING THE INVESTIGATION, IT WAS FOUND THAT THE CUTTERS FAILED THE CUT TEST. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25016082 ↗
• 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 24967491 ↗
• 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 23019720 ↗
• MalfunctionJul 23, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE DEVICE WAS FOUND IN NEED OF REPAIR AS CUTTER FAILED THE TEST CUT. 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 22576443 ↗
• MalfunctionMay 12, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY THE CUTTER CAUSED DAMAGE TO THE TAKEN GRAFT. AN ADDITIONAL GRAFT WAS NOT NEEDED. THERE WAS NO PATIENT IMPACT AND THERE WAS NO DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Graft failure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001685 ↗
• MalfunctionApr 23, 2025Prophylactic removal due to corrective action; Prophylactic removal due to corrective action

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE DEVICE WAS SENT IN FOR PREVENTIVE MAINTENANCE. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE CUTTER FAILED THE TEST CUT. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. 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 21891797 ↗
• 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 20916174 ↗
• MalfunctionSep 30, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SURGERY THE SKIN GRAFT MESHER BUNCHED THE SKIN GRAFT INSIDE THE MESHER. THE GRAFT WAS REMOVED WITHOUT HARM AND PROCEEDED TO FINISH THE CASE WITH AN ALTERNATE DEVICE. THERE WAS NO PATIENT IMPACT OR INVOLVEMENT. DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER DID NOT PASS THE MESH TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339092 ↗
• MalfunctionJun 10, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE HAD PROBLEMS WITH CUTTING. THERE WAS NO HARM, INJURY OR DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. AFTER EVALUATION OF THE RETURNED DEVICE, IT WAS DETERMINED THAT THE CUTTER FAILED TO THE TEST CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19500816 ↗
• MalfunctionMay 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE ROLLER COLLARS NEED REPLACED. NO PATIENT INVOLVEMENT OR IMPACT. THE DEVICE FAILED THE TEST CUT DURING EVALUATION. DUE DILIGENCE INFORMATION COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372347 ↗
• MalfunctionMar 4, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE CUTTER IS NOT NOT CUTTING CONSISTENTLY DURING SURGERY. THERE WAS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827641 ↗
• 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 18239874 ↗
• MalfunctionNov 30, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE PLASTIC RULER WAS STUCK IN THE MESHER. THERE WAS NO PATIENT INVOLVEMENT, IMPACT, OR HARM REPORTED. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION AVAILABLE. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER FAILED THE TEST CUT 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 18236559 ↗
• 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 18077598 ↗
• 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 17975547 ↗
• MalfunctionOct 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEVICE WAS RETURNED FOR PREVENTATIVE MAINTENANCE. THE EVENT OCCURRED OUTSIDE OF SURGERY. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE EVALUATION FOUND THE CUTTER FAILED THE TEST CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974515 ↗
• 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 17876333 ↗
• 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 17842530 ↗
• 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 17697938 ↗
• 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 17623959 ↗
• 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 HAD BLUNT SPOTS AND 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 17622571 ↗
• MalfunctionAug 8, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE TIP OF THE MESHER WHERE THE HANDLE IS BEING PLACED IS BROKEN/MUNTED. IT SEEMS THAT THE HANDLE WAS FORCED TO PUT ON THE SIDE TIP WHEN USED IN THEATRE RESULTING THE HANDLE DIFFICULT TO BE TAKEN OFF OFF. DURING THE PRODUCT INVESTIGATION IT WAS DETERMINED THAT THE CUTTER FAILED THE TEST CUT. THERE WERE NO REPORTED HARM/INJURY TO PATIENT OR USER NEITHER WERE THERE ANY REPORTED DELAY. DUE DILIGENCE IS COMPLETE. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482557 ↗
• MalfunctionAug 2, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A DEMONSTRATION, THE DEVICE SEEMED TOO TOUGH TO USE AND WAS TEARING THE DONOR SKIN. THERE WAS NOTHING NOTICEABLY BROKEN ON THE MESHER AND IT SEEMED TO BE ASSEMBLED CORRECTLY BUT IT WAS TEARING THE SKIN AS IT WAS PUT THROUGH THE MESHER ON THE CARRIER. DURING PRODUCT EVALUATION, 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 17442738 ↗
• 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 17333566 ↗