n.a. 277KERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551090206), received between Mar 24, 2021 and Mar 24, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2021Circuit Failure; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Circuit Failure; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): PATIENT POSITIONED IN LITHOTOMY POSITION AND PREPARED FOR TUR; BLEEDING OCCURRED IN VESICA, CURRENT SUDDENLY COULD NOT BE TRIGGERED, BLEEDING COULD NOT BE STOPPED EVEN WITH 2ND PREPARED INSTRUMENT (ALSO NO CURRENT FLOW ENSURED). DUE TO THIS AND TO FURTHER REDUCE PATIENT'S DAMAGE, PROCEDURE HAD TO BE CHANGED TO OPEN SURGERY. THIS REPORT IS FOR THE SECOND INSTRUMENT THAT FAILED DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11565740 ↗
• MalfunctionMar 24, 2021Circuit Failure; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Circuit Failure; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): PATIENT POSITIONED IN LITHOTOMY POSITION AND PREPARED FOR TUR; BLEEDING OCCURRED IN (B)(6), CURRENT SUDDENLY COULD NOT BE TRIGGERED, BLEEDING COULD NOT BE STOPPED EVEN WITH 2ND PREPARED INSTRUMENT (ALSO NO CURRENT FLOW ENSURED). DUE TO THIS AND TO FURTHER REDUCE PATIENT'S DAMAGE, PROCEDURE HAD TO BE CHANGED TO OPEN SURGERY. THIS REPORT IS FOR THE FIRST INSTRUMENT THAT FAILED DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11565739 ↗