n.a. 26055SCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551306727), received between Nov 4, 2024 and Aug 5, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50146856 ↗
• InjuryNov 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A "FLUID LEAKAGE WAS OBSERVED DURING BIPOLAR RESECTION OF UTERINE POLYPS. THE LEAKAGE WAS SO INTENSE THAT THE PROCEDURE HAD TO BE INTERRUPTED. POLYPS WERE NOT REMOVED. THE LEAK OCCURRED FROM THE SHEATH AND THE WORKING ELEMENT. THE PROCEDURE HAS NOT BEEN COMPLETED". NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20600071 ↗