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ATRAUMATA FB495RRecalls & reported problems

Aesculap AG · OCHSNER ATRAUMATA Aorta Clamp, angled, 10 1/4", (260 mm), satinsky-shaped, toothing DE BAKEY, (93 mm), width: 50 mm, non-sterile, reusable · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653156429), received between Sep 18, 2020 and Sep 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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

Device problems

  • Mechanical Problem1

Patient problems

  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

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

  • InjurySep 18, 2020Mechanical Problem; Mechanical Problem

    ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00444 (400482527 - FB495R - QUANTITY: 3).

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 10554714 ↗

Other CLAMP devices

All CLAMP devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.