AESCULAP FF805RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653044597), received between Mar 10, 2021 and Jun 15, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2023Material Fragmentation; Material Fragmentation

  INVESTIGAITON COMPLETE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17133753 ↗
• MalfunctionFeb 11, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED TO AESCULAP AG THAT AN LOVE-GRUENWALD RONGEUR (PART # FF805R) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PIN FROM THE JOINT FELL OUT DURING THE PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 9610612-2022-00019, 9610612-2022-00039.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13516028 ↗
• MalfunctionMar 10, 2021Material Twisted/Bent; Material Twisted/Bent

  ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00151 ((B)(6) +FF805R) AND 9610612-2021-00152 ((B)(6) +FF806R).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11455610 ↗