NA 011024Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010023056), received between Feb 15, 2021 and Jul 13, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE GRASPER ALLIGATOR MAX TIP CAME OUT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491208 ↗
• InjuryNov 20, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE ALLIGATOR MAX GRASPER BROKE WHILE TAKING A SUB-CENTIMETER CALCIFICATION. UNSUCCESSFULLY, THE DEPARTMENT TRIED TO RECOVER THE BROKEN PIECE UNDER ARTHROSCOPY, THEY ALSO TRIED CONVERSION WITH ARTHROTOMY, WHICH FAILED, WITH MIGRATION OF THE BROKEN PIECE INTO THE MUSCULAR SOFT TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18171709 ↗
• MalfunctionOct 8, 2021Break; Break

  IT WAS REPORTED THAT THE GRASPER ALLIGATOR MAX BROKE OUT FROM THE SHAFT. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12600572 ↗
• InjuryFeb 15, 2021Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGERY THE GRASPER TIP BROKE OFF. AN ADDITIONAL INCISION WAS MADE IN ORDER TO REMOVE ALL THE BROKEN PIECES. NO OTHER COMPLICATIONS WERE REPORTED. IT IS UNKNOWN IF THERE WAS A DELAY AND HOW THE SURGERY WAS COMPLETED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11330576 ↗