AESCULAP FH912BRecalls & reported problems
Aesculap AG · Rongeur detachable, 150 °, angled upwards, 7" (180 mm), smooth, jaw width: 2 mm, stainless steel · Class 1
Data updated Oct 18, 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 04046964608407), 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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)- FH914B), 9610612-2020-00458 ((B)(4) - FH913B).
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10480177 ↗
Other RONGEUR devices
- SPOTLIGHT 292904201Depuy Spine, LLC · RONGEUR6 reports
- SPOTLIGHT 292904202Medos International Sàrl · RONGEUR5 reports
- Symmetry RapidClean® 58-3200J-BDAspen Surgical Products, Inc. · Rongeur5 reports
- NA 03.605.001Synthes GmbH · RONGEUR4 reports
- Medicon 57.28.33Medicon eG. Chirurgiemechaniker-Genossenschaft · RONGEUR3 reports
- Symmetry Rapidclean® 58-3200-BDAspen Surgical Products, Inc. · Rongeur3 reports
- AESCULAP FF805RAesculap AG · RONGEUR3 reports
- Integra® Jarit® 280405Integra Lifesciences Production Corporation · RONGEUR3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page