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AESCULAP FF562RRecalls & reported problems

Aesculap AG · CASPAR Rongeur, straight, 7 1/4" (185 mm), serrated, 2 x 12 mm · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653044153), received between Apr 27, 2021 and Apr 28, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2
  • Material Integrity Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • InjuryApr 28, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

    IT WAS REPORTED TO AESCULAP INC. THAT A CASPAR RONGEURSTRSERR 2X12MM185MM (PART # FF562R) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PIECE OF THE INSTRUMENT BROKE AWAY AND DETACHED INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED UNDER FLOUROSCOPY. THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE FRAGMENT RETRIEVAL. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11739637 ↗
  • InjuryApr 27, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

    IT WAS REPORTED TO AESCULAP INC. THAT A CASPAR RONGEURSTRSERR 2X12MM185MM (PART # FF562R) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PIECE OF THE INSTRUMENT BROKE AWAY AND DETACHED INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED UNDER FLOUROSCOPY. THE COMPLAINT DEVICE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE FRAGMENT RETRIEVAL. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11734992 ↗

Other RONGEUR devices

All RONGEUR devices →

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