NA 011014Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010022936), received between Oct 5, 2021 and Jun 6, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY WITH ACL FLEXORS, WHEN ONE (1) CUPPED GRASPER WAS INSIDE THE PATIENT, WHILE ATTEMPTING TO PULL THE MENISCUS, THE GRASPER BROKE INSIDE THE PATIENT'S JOINT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25419466 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY + ACL PROCEDURE, A GRASPER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25010476 ↗
• MalfunctionDec 26, 2022Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC ROTATOR CUFF REPAIR, THE GRASPER WAS BROKEN, THE JAWS FAILED TO CLOSE AND LOCK. IT WAS REMOVED FROM THE PATIENT AND INSPECTED. THE SCRUB TECH TRIED TO OPEN AND CLOSE THE GRASPER AND THE TOP OF THE JAWS AND THE ARTICULATION ROD CAME APART. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048568 ↗
• InjuryDec 15, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE GRASPER BROKE. ALL PIECES WERE REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITHOUT DELAY, HOWEVER, IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15985893 ↗
• MalfunctionSep 23, 2022Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, THE GRASPER WAS BROKEN. THERE WAS A BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470224 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE GRASPER DEVICE WAS NOT GRASPING TIGHTLY, THE INSTRUMENT WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585481 ↗
• MalfunctionOct 5, 2021Break; Unstable; Break; Unstable

  IT WAS REPORTED THAT THE GRASPER HAS FALLEN APART. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580089 ↗