AESCULAP GA395SURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964498756), received between Jan 4, 2021 and Jan 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 4, 2021Manufacturing, Packaging or Shipping Problem; Component Misassembled; Manufacturing, Packaging or Shipping Problem; Component Misassembled

  IT WAS REPORTED TO AESCULAP AG THAT AN ELAN 4 ELECTRO DISPOSABLE TUBE SET (PART # GA395SU) WAS TO BE USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE INLET AND OUTLET FOR THE RINSING HOSE ADAPTER APPEARED TO BE INCORRECTLY ASSEMBLED. REPORTEDLY, THE SYSTEM PUMPED AIR INTO THE FLUSH SOLUTION BOTTLE. THE DEVICE ISSUE WAS OBSERVED PRIOR TO THE START OF THE PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. THE MALFUNCTION WAS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11109456 ↗