AESCULAP OG300RRecalls & reported problems
Aesculap AG · DIETER Malleus Nipper, upwards cutting, 3", (75 mm), non-sterile, reusable · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653051588), received between Sep 10, 2021 and Mar 17, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
Device problems
- Material Fragmentation2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED TO AESCULAP AG THAT A DIETER MALLEUS NIPPER UP-CUT 75MM (PART # OG300R) WAS USED DURING A CHOLEOSTEATOME REMOVAL PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INSTRUMENT BROKE. REPORTEDLY, THE SURGEON NOTICED A PIECE OF METAL IN THE EAR. AFTER RETRIEVAL, THE FRAGMENT WAS DETERMINED TO BE FROM THE OG300R DEVICE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. . AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. NO ADVERSE PATIENT OUTCOME WAS REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13792837 ↗MalfunctionSep 10, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH OG300R - DIETER MALLEUS NIPPER UP-CUT 75MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PART OF THE TIP HAS BROKEN OFF WHEN CUTTING A PIECE OF BONE. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: Insufficient Information
MAUDE report 12454230 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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