AESCULAP GK375RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653457847), received between Jun 4, 2021 and Jun 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2021Break; Melted; Break; Melted

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GK375R-INNER TUBE W/HANDLE FOR GK374R. ACCORDING TO THE COMPLAINT DESCRIPTION, THE HOOK INSULATION FAILED DURING SURGERY. DURING A LAPAROSCOPIC PROCEDURE THERE WAS BLEEDING AND THE CURRENT CAUTERY SETTING WAS NOT EFFECTIVE IN CONTROLLING THE BLEEDING SO THE CAUTERY SETING WAS INCREASED. IT WAS NOT NOTICED UNTIL THE END OF THE CASE, WHEN THE INSTRUMENTS WERE DECONTAMINATED, THAT THE INSULATION APPEARED TO BE MELTED. THERE WAS NO DESCRIBED PATIENT HARM OR SURGICAL DELAY. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00318 ((B)(4) GK383R).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938838 ↗