N/A 00-7703-040-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00889024375475), received between Jan 12, 2021 and Nov 21, 2025 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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. 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 27 reports, in the reporter's own words as published by the FDA.

• 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. AFTER FINAL INVESTIGATION, IT WAS CONFIRMED THAT THIS CUTTER FAILED THE CUT TEST. THERE WAS NO INFORMATION AVAILABLE REGARDING THE PATIENT IMPACT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23619523 ↗
• 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 22576564 ↗
• 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 20918625 ↗
• 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 20520409 ↗
• 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 19212130 ↗
• 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 18238535 ↗
• 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 18077347 ↗
• 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 17975727 ↗
• 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 17873012 ↗
• 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 17842503 ↗
• InjurySep 12, 2023Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE ACCOUNT JUST RECEIVED TWO 4:1 CUTTERS AND BOTH CUTTERS THEY TRIED ON DIFFERENT MESHERS COMPLETED DESTROYED THE GRAFT. THE EVENT OCCURRED DURING SURGERY. AN ADDITIONAL UNPLANNED SKIN GRAFT WAS NEEDED IN ORDER TO COMPLETE THE SURGERY. THERE WAS NO EXCESSIVE DELAY REPORTED BEYOND THE TIME TO OBTAIN A NEW DEVICE. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 17728353 ↗
• InjurySep 12, 2023Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE ACCOUNT JUST RECEIVED TWO 4:1 CUTTERS AND BOTH CUTTERS THEY TRIED ON DIFFERENT MESHERS COMPLETED DESTROYED THE GRAFT. THE EVENT OCCURRED DURING SURGERY. AN ADDITIONAL UNPLANNED SKIN GRAFT WAS NEEDED IN ORDER TO COMPLETE THE SURGERY. THERE WAS NO EXCESSIVE DELAY REPORTED BEYOND THE TIME TO OBTAIN A NEW DEVICE. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 17728296 ↗
• 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 17624000 ↗
• MalfunctionAug 4, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SURGERY THE MESHER MALFUNCTIONED WITH ROLLER NO. 4. THERE WAS NO HARM REPORTED. A 0 TO 15 MINUTE EXTENSION OF SURGERY OCCURRED TO PREPARE AN ALTERNATE DEVICE TO COMPLETE THE PROCEDURE. NO ADDITIONAL SKIN GRAFT WAS REQUIRED. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT EVALUATION INVESTIGATION 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 17458888 ↗
• MalfunctionJul 17, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING PRODUCT EVALUATION, THE CUTTER FAILED THE TEST CUT WITH AN INCOMPLETE CUT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333570 ↗
• MalfunctionJun 28, 2023Failure to Cut; Failure to Cut

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216340 ↗
• MalfunctionJun 23, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE THE CUTTER IS DAMAGED. THERE WAS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. UPON INVESTIGATION, THE CUTTER FAILED THE CUT TEST WITH AN INCOMPLETE CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189952 ↗
• MalfunctionFeb 28, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING MAINTENANCE THE CUTTER WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. UPON EVALUATION, IT WAS FOUND THAT THIS CUTTER DID NOT PASS THIS SAMPLE GRAFT CUT TEST. DUE DILIGENCE HAS BEEN COMPLETED AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. NO ADVERSE EVENTS WERE RECORDED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455572 ↗
• MalfunctionFeb 15, 2023Failure to Cut; Failure to Cut

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379192 ↗
• MalfunctionSep 15, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING ANNUAL/PREVENTATIVE MAINTENANCE, IT WAS NOTED THAT THE DAMAGED BOTTOM ROLL AND SEVERAL DAMAGED CUTTERS NEEDED TO BE REPLACED. EVALUATION LATER FOUND THAT THIS CUTTER DID NOT PASS THE SAMPLE MESH CUT TEST. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427954 ↗
• MalfunctionJun 27, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE CUTTER WAS NOTED TO BE DAMAGED. UPON EVALUATION IT WAS NOTED THE CUTTER FAILED THE CUTTING TEST. NO HARM OR DELAY WERE REPORTED AND NO OTHER ADVERSE EVENTS WERE REPORTED ALONG WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14829349 ↗
• MalfunctionMay 18, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE IS NOT WORKING BEFORE SURGERY. THERE WAS NO DELAY AND NO PATIENT INVOLVEMENT. EVALUATION OF THIS DEVICE LATER FOUND THAT THIS CUTTER FAILED A CUT TEST. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427055 ↗
• MalfunctionMar 30, 2022Material Deformation; Material Twisted/Bent; Naturally Worn; Material Deformation; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED DURING ROUTINE MAINTENANCE THE DAMAGED COMB, WORN SHOULDER BOLTS , AND DAMAGED CUTTERS NEEDED TO BE REPLACED. CUTTER FAILED CUT TEST AT PRODUCT EVALUATION INVESTIGATION. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13953354 ↗
• MalfunctionJan 26, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION PRIOR TO SURGERY. AT PRODUCT EVALUATION INVESTIGATION THIS CUTTER DID NOT PASS THE CUT TEST. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13360517 ↗
• MalfunctionMay 4, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED DEVICES NEED REPAIRED FOR UNKNOWN REASON. NO PATIENT INVOLVEMENT. THERE IS NO ADDITIONAL INFORMATION. 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 11768885 ↗