n.a. 279KBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551090862), received between Nov 5, 2018 and Apr 30, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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.

• MalfunctionApr 30, 2019Sparking

  ALLEGEDLY, THERE WAS A SPARK NOTICED WHEN USING THE CORD INSIDE THE PATIENT DURING A PROCEDURE. IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8565987 ↗
• MalfunctionNov 5, 2018Material Frayed; Smoking

  SURGEON WAS CAUTERIZING BLADDER BLEEDING AND SMOKE STARED COMING FROM THE GREY ELECTRICAL CORD. THE CORD WAS IMMEDIATELY DISCONNECTED AND TAKEN OUT OF SERVICE. THE END OF CORD THAT WAS ON FIELD WAS FRAYED AND BLACKENED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8037347 ↗