N/A 00-7701-000-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 521 adverse event reports that list this exact device (DI 00889024375390), received between Feb 25, 2020 and Sep 24, 2026 — classified as 9 injuries, 512 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (187 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 521 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889723 ↗
• MalfunctionSep 16, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Insufficient Information

  MAUDE report 50796472 ↗
• MalfunctionSep 8, 2026Mechanical Problem

  It was reported that during kit inspection the ratchet handle is faulty. There was no patient involvement. Upon evaluation it was identified that the comb was damaged. Due diligence is complete.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672604 ↗
• MalfunctionAug 24, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50404866 ↗
• MalfunctionJul 27, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035534 ↗
• MalfunctionJul 15, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25829065 ↗
• MalfunctionJul 15, 2026Component Missing; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25823970 ↗
• MalfunctionJul 13, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25794909 ↗
• MalfunctionJul 9, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT REQUIRES PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT. DURING THE INVESTIGATION, IT WAS FOUND THAT THE COMB IS DAMAGED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25768418 ↗
• MalfunctionJul 6, 2026Material Twisted/Bent

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE PLATE ATTACHED TO THE HANDLE WAS BENT AND IS DAMAGED BEYOND USE. THERE WAS NO PATIENT INVOLVEMENT. DURING THE INVESTIGATION, IT WAS FOUND THAT THE COMB WAS DAMAGED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25723331 ↗
• MalfunctionJun 29, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE MESH GRAFTER WAS SENT IN FOR REPAIR. THE HANDLE WAS STUCK. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT OR HARM. DURING DEVICE EVALUATION, THE HANDLE WAS STUCK AND GEAR WAS DAMAGED AND REPLACE. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE TO THE CUSTOMER; HOWEVER, NO RESPONSE WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 25650183 ↗
• MalfunctionJun 22, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT OUTSIDE OF SURGERY ON AN UNKNOWN DATE, THE DEVICE WAS IN NEED OF CORRECTIVE REPAIR. INVESTIGATION RESULTS INDICATE THAT UNIT HAD DAMAGED COMB. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25576599 ↗
• MalfunctionMay 28, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING TESTING THE MESHER WAS NOT WORKING. NO PATIENT INVOLVEMENT. UPON DEVICE EVALUATION IT WAS NOTED THAT THE COMB ON THE DEVICE WAS NOTED TO BE DAMAGED. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFO WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25316363 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED AN UNKNOWN TIME, ON AN UNKNOWN DATE, THE DEVICE'S RACHET MECHANISM WAS NOT WORKING, IT WAS BROKEN. DURING INVESTIGATION IT WAS FOUND THAT RATCHET GEAR WAS STUCK AND THE COMB WAS DAMAGED. THERE WAS NO NOTE OF PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETED, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25217136 ↗
• MalfunctionApr 30, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING TESTING, THE UNIT HAD AN UNKNOWN ISSUE. DAMAGED COMB WAS CONFIRMED AFTER FINAL ASSESSMENT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046021 ↗
• MalfunctionApr 28, 2026Misassembled

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, DURING INSPECTION, THE CYLINDRICAL METAL MESH INSIDE WAS MOUNTED UPSIDE DOWN MAKING THE DEVICE UNUSABLE. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE COMB WAS TURNED OVER AND VERY DEFORMED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015263 ↗
• MalfunctionApr 23, 2026Component Missing; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION, THE UNIT HAD A DAMAGED LOWER MESH GUARD AND A SCREW MISSING FROM THE RATCHET HANDLE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968094 ↗
• MalfunctionApr 21, 2026Positioning Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE ONE OF THE LOCKING PINS IS POORLY FITTED MAKING IT VERY DIFFICULT TO HANDLE WITH BARE HANDS. IT IS DIFFICULT TO INSERT AND TAKE OUT OF LOCK/UNLOCK. THERE WAS NO PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE HANDLE WOULD NOT EASILY FIT ONTO THE MESHER BASE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940469 ↗
• MalfunctionApr 13, 2026Material Twisted/Bent

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE METAL WHERE THE ROLLER SITS WAS BENT. 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 24861125 ↗
• MalfunctionApr 13, 2026Failure to Advance

  IT WAS REPORTED THAT BEFORE SURGERY THE SKIN WAS NOT GOING THROUGH. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858943 ↗
• MalfunctionMar 26, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE DEVICE, SENT IN FOR PREVENTIVE MAINTENANCE, AND WAS FOUND TO HAVE A FAULT AT A REPAIR CENTER. THE UNIT INSPECTION DURING INVESTIGATION IDENTIFIED A DAMAGED COMB. THERE WAS NO PATIENT INVOLVEMENT. DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698545 ↗
• MalfunctionMar 24, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY, A DENT WAS OBSERVED ON THE THIN METAL PART OF DEVICE. NO INFORMATION WAS PROVIDED AS IT RELATES TO PATIENT HARM OR SURGICAL DELAY. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION WAS NOTED.

  Patient problems: Insufficient Information

  MAUDE report 24675719 ↗
• MalfunctionMar 23, 2026Failure to Advance

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE IS NOT RATCHETING AND THE CARRIER IS NOT GOING ALL THE WAY THROUGH THE MESHER. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT OR DELAY. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24662341 ↗
• MalfunctionMar 17, 2026Failure to Advance

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE SPECIMEN CONTINUOUSLY GOT CAUGHT ON WHEEL. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619390 ↗
• MalfunctionMar 4, 2026Material Too Rigid or Stiff

  IT WAS REPORTED THAT DURING DECONTAMINATION THE MESHER WAS TIGHT AND DID NOT ARTICULATE FREELY. THE HANDLE WAS ABLE TO MOVE UP AND DOWN, BUT ARTICULATION REMAINED RESTRICTED NO SURGICAL DELAY OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION IT WAS NOTED THAT THE DEVICE HAD A DAMAGED COMB. DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511910 ↗