AESCULAP FB805RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653157945), received between Feb 11, 2021 and Feb 11, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Jam” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2021Mechanical Jam; Mechanical Jam

  THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11318037 ↗
• InjuryFeb 11, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED TO AESCULAP INC. THAT A FINOCHIETTO-BURFORD RIB SPREADER (PART # (B)(4)) WAS USED DURING A THORACIC SURGERY PERFORMED IN (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO OPEN OR CLOSE THE CHEST RETRACTOR AFTER IT WAS PLACED INSIDE THE PATIENT. REPORTEDLY, THE PATIENT EXPERIENCED A MAJOR BLEED OF THE PULMONARY ARTERY, AND BECAUSE THE DEVICE WAS NOT ABLE TO BE OPENED, THE SURGEON WAS NOT ABLE TO FULLY ACCESS THE BLEED SITE TO SEW THE WOUND. AFTER APPROXIMATELY FIFTEEN (15) MINUTES OF STRUGGLING WITH THE DEVICE, IT WAS ABLE TO BE FREED AND REMOVED. THE SURGEON WAS THEN ABLE TO ADDRESS THE BLEED AND SUCCESSFULLY COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONALLY, THE DEVICE WAS NOTED AS BEING APPROXIMATELY TWO (2) YEARS OLD. THE PATIENT'S CONDITION WAS NOTED AS BEING "FINE" AT THE CONCLUSION OF THE PROCEDURE. ADDITIONALLY, THE REPORTER CONFIRMED THAT THE PATIENT WAS STABLE POST OPERATIVELY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11317958 ↗