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AESCULAP FH913BRecalls & reported problems

Aesculap AG · Rongeur detachable, 150 °, angled upwards, 7" (180 mm), smooth, jaw width: 3 mm, stainless steel · Class 1

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 04046964608414), received between Sep 1, 2020 and Sep 1, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Erosion” (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

  • Appropriate Device Problem Term/Code Not Available1
  • Material Erosion1
  • Peeled/Delaminated1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionSep 1, 2020Material Erosion; Peeled/Delaminated; Appropriate Device Problem Term/Code Not Available; Material Erosion; Peeled/Delaminated; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A RONGEUR. ACCORDING TO THE COMPLAINT DESCRIPTION THE SURFACE QUALITY CHANGED. AFTER 9 TIMES OF PREPARATION THE COATING DISSOLVES AND THE SURFACE CONDITION HAS CHANGED. THERE ARE ALSO UNEVENNESSES IN THE MATERIAL. FOUND PRIOR TO USE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00457 (B)(4), 9610612-2020-00459 (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10480175 ↗

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.