n.a. 11274FERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551050545), received between Jan 31, 2025 and Feb 26, 2025 — classified as 2 malfunctions.

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 18, 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.

• MalfunctionFeb 26, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED IN THE BEGINNING OF THE SURGERY, THE CLAMP WORKED CORRECTLY, BUT DURING THE SURGERY, THE CLAMP STOPPED CLOSING WITH THE FORCE THAT IT WAS INITIALLY DOING. SO, THE DOCTORS HAD TO CHANGE THE CLAMP DURING SURGERY. THIS WAS WHAT CAUSED THE PROLONGATION 20-25 MIN OF IT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470504 ↗
• MalfunctionJan 31, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT PROBLEM THE JAWS OF THE GRASPER BROKE OFF INSIDE THE PATIENT. THE BROKEN FOREIGN BODY WAS REMOVED WITH ANOTHER GRASPER AND ALL PIECES WERE CONFIRMED REMOVED FROM THE PATIENT. STAFF ALSO REPORTED THAT THE GRASPER OFTEN DOES NOT OPEN WHEN TRIGGERED BY THE PROCEDURALS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289193 ↗