AESCULAP GK398RRecalls & reported problems
Aesculap AG · MONOPOLAR HOOK ELECTRODE 3.5MM 290MM · Class 2
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 04046963520717), received between Nov 8, 2021 and Nov 8, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 Split, Cut or Torn2
- Fracture1
Patient problems
- Burn(s)1
- 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.
MalfunctionNov 8, 2021Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn
IT WAS REPORTED TO AESCULAP AG THAT A MONOPOLAR HOOK ELECTRODE 3.5MM 290MM (PART # GK398R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE DEVICE INSULATION CRACKED NEAR THE DISTAL TIP. REPORTEDLY, THE INSTRUMENT CAUTERIZED AN UNINTENDED AREA OF THE LIVER. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT HARM WAS REPORTED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12775509 ↗InjuryNov 8, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
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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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