ELAN 4 GA707RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963835309), received between May 4, 2021 and May 4, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GA707R - ELAN 4 AIR MOTOR HOSE 5M W/HAND CONTROL. ACCORDING TO THE COMPLAINT DESCRIPTION, THE HINGE SCREW OF THE GA707R HAND SWITCH IS DAMAGED. THE CUSTOMER NOTICED THAT THE SCREW HAD COME OFF DURING THIS SURGERY. IT SEEMS THAT FRAGMENTS OF MALE SCREWS REMAIN INSIDE THE SCREWS THAT HAVE COME OFF. THE CUSTOMER SEARCHED FOR IT DURING SURGERY BUT COULD NOT FIND A HALF-SPLIT SCREW. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11769752 ↗