ENNOVATE SZ405RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964719578), received between Nov 7, 2021 and Nov 7, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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 18, 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.

• InjuryNov 7, 2021Material Separation; Material Separation

  IT WAS REPORTED TO AESCULAP AG THAT A SZ405R-ENNOVATE FRI DOWNTUBE SHORT (PART # SZ405R) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE OPERATION WAS PERFORMED WITHOUT ANY COMPLICATIONS OR PROBLEMS. AFTER THE OPERATION, THE SURGEON DISCONNECTED THE TUBES, ACCORDING TO THE SURGICAL PROCEDURE USING THE SZ380R INSTRUMENT. DURING THE FOLLOW-UP X-RAY EXAMINATION, A BROKEN PIECE FROM THE SZ405R INSTRUMENT WAS IDENTIFIED IN THE PATIENT. REOPERATION WAS PERFORMED AND THE PART WAS REMOVED. THE PATIENT WAS NOT INJURED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12760394 ↗