Skip to content

ATRAUMATA FB411RRecalls & reported problems

Aesculap AG · DE BAKEY ATRAUMATA Atraumatic Forceps, straight, 6", (150 mm), toothing DE BAKEY, width: 1,500 mm, non-sterile, reusable · Class 1

All models of ATRAUMATA (39)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653043279), received between May 11, 2023 and May 11, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Human-Device Interface 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Human-Device Interface Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 11, 2023Human-Device Interface Problem; Human-Device Interface Problem

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FB411R - DE'BAKEY ATR.FCPS 1.5MM STR150MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE ONCE TORE TISSUE DURING A HERNIA PROCEDURE. IT WAS NOTED THAT THE "TEETH" DID NOT APPROXIMATE CORRECTLY. A TEMPORARY IMPAIRMENT OCCURRED; THERE WAS NO FURTHER PATIENT HARM NOR SURGICAL DELAY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16913152 ↗

Other FORCEPS devices

All FORCEPS devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page