GAMMA 1320-0340Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540504296), received between Mar 23, 2022 and May 23, 2023 — 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 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.

• MalfunctionMay 23, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "A PART OF U-BLADE INSERTER WAS BROKEN OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986342 ↗
• MalfunctionMar 23, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "DURING U-BLADE INSERTION, THE PIN OF THE INSERTER BROKE OFF."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860402 ↗