AESCULAP GN060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653078035), received between Nov 25, 2020 and Apr 27, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2021Power Problem; Power Problem

  IT WAS REPORTED TO AESCULAP AG THAT A BIPOLAR COAGULATION UNIT (PART # GN060) WAS TESTED PRIOR TO A PROCEDURE SET TO BE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, PRIOR TO THE OPERATION, THE BIPOLAR COAGULATOR WAS TESTED, AND WAS FOUND TO HAVE NO OUTPUT. THE DEVICE WAS REPLACED. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734657 ↗
• MalfunctionApr 19, 2021Fitting Problem; Activation Problem; Fitting Problem; Activation Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GN060-BIPOLAR COAGULATION UNIT AS PER INFORMATION RECEIVED VIA MEDWATCH (B)(4). ACCORDING TO THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT THE FOOT PEDAL WOULD ONLY ACTIVATE THE UNIT INTERMITTENTLY. NEURO LEAD AND BIOMED CALLED TO ROOM TO TROUBLE SHOOT. SURGEON CONTINUED TO HAVE ISSUES WITH THE FOOT PEDAL ACTIVATION. THE ONLY OTHER MALIS BIPOLAR UNIT BROUGHT IN THE ROOM AND SET UP BY NEURO LEAD BUT THE OTHER FOOT PEDAL ROUTINELY USED COULD NOT BE LOCATED. SURGEON COULD NOT SUBSTITUTE WITH ANY OTHER CAUTERY AND HAS TO FINISH CASE WITH MALFUNCTIONING UNIT. ORIGINAL INTENDED PROCEDURE: RADICULOPATHY LUMBAR. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11690228 ↗
• MalfunctionNov 25, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10906735 ↗