NA 7207699Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010462923), received between Mar 16, 2021 and Jun 29, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2023Break; Break

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE GRASPER ALLIGATOR MAX BROKE WHEN TRYING TO GRAB A BONE FRAGMENT. THE PIECE OF GRASPER AND THE SMALL BONE PIECE DISAPPEARED INTO THE SOFT TISSUE, IT COULD BE SEEN FLUOROSCOPICALLY, BUT IT WAS NOT POSSIBLE TO BE FOUND WITH THE ARTHROSCOPE SO IT WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 20 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17228411 ↗
• MalfunctionMar 16, 2021Break; Break

  IT WAS REPORTED THAT THE GRASPER ALLIGATOR MAX WAS BROKEN INTO TWO PARTS. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING THE ARTHROSCOPY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11499064 ↗