NA 011021Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010022998), received between Mar 25, 2019 and Mar 5, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT, DURING A MENISCUS SURGERY, THE UPPER CLAW OF AN ALLIGATOR GRASPER BROKE INSIDE THE PATIENT. THE DEVICE WAS REMOVED BY SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518607 ↗
• InjurySep 24, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BODY OF THE GRASPER BROKE APART. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE AND IF A DELAY HAPPENED IN THE PROCEDURE. HOWEVER, NO PATIENT 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; No Information

  MAUDE report 10583568 ↗
• MalfunctionMay 7, 2019Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE BROKE DOWN. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY NOR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8588462 ↗
• MalfunctionMar 25, 2019Break

  IT WAS REPORTED THAT DURING A MENISCUS RESECTION, THE MOBILE PART OF THE WORKING PART OF THE DEVICE BROKE OFF. THE PIECE REMAINED IN THE KNEE JOINT. THERE WAS A DELAY OF MORE THAN 60 MINUTES. THE DOCTOR DID NOT HAVE A BACKUP DEVICE AVAILABLE, SO AN ARTHROTOMY WAS EXECUTED. THE EXTRACTION OF THE FRAGMENT WAS NOT CARRIED OUT, THE PATIENT IS DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8448302 ↗
• MalfunctionMar 25, 2019Break

  IT WAS REPORTED THAT DURING THE OPERATION THE CLAMP BROKE. THE OPERATION COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8446977 ↗