NA 815033Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207000236), received between Nov 16, 2018 and Feb 9, 2024 — classified as 3 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 9, 2024Material Separation; Electrical Shorting; Material Separation; Electrical Shorting

  AN IMPORTER HAS INFORMED RICHARD WOLF GMBH (RWGMBH) OF AN ISSUE REGARDING A HF CONNECTION CABLE MONO L 3M, PART ID: 815.033, SN/BATCH# UNKNOWN. THE INFORMATION WAS RECEIVED FROM A "USER-NOTIFICATION" REPORT NO. (B)(4). ACCORDING TO THE REPORT, THE CORD SHORTED OUT AND BLEW APART. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT'S OUTCOME OR ANY OTHER RISKS OR INJURIES. IT IS ALSO NOT KNOWN IF THERE WAS A TIME DELAY IN THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18678857 ↗
• MalfunctionOct 29, 2020Break; Temperature Problem; Break; Temperature Problem

  ON FEBRUARY 4TH, 2021, RWMIC RECEIVED THE FOLLOWING INFORMATION FROM THE SALES REP: IN DISCUSSIONS WITH THE USER FACILITY AND THE DOCTOR IT WAS DETERMINED THAT IT WAS A MEDTRONIC GENERATOR CAUSING THE ISSUE. THE CUSTOMER WAS HAVING TO USE 3-4 LOOPS PER TURP. WE EXCHANGED OUT THE GENERATOR IN THE CYSTO ROOM AND FOUND IT WAS THE MEDTRONIC GENERATOR THAT WAS CAUSING THE LOOPS TO BURN OUT. THE CUSTOMER HAS SEND THE MEDTRONIC GENERATOR FOR REPAIR AND IS USING ONE OUT OF ANOTHER ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10756256 ↗
• MalfunctionNov 16, 2018Sparking; Sparking

  FOLLOW-UP REPORT #2 IS TO PROVIDE FDA WITH NEW AND CHANGED INFORMATION. USER FACILITY RETURNED THE DEVICE TO RWMIC ON (B)(6) 2018, AND THE EVALUATION WAS COMPLETED ON (B)(6) 2019. THE CABLE WAS INSPECTED AND THE CABLE WAS FOUND TO BE BROKEN. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE WEAR AND TEAR. THE CAUSE FOR THE WIRE BREAKAGE IS THE USE OF THE CABLE. UP TO THE ABSOLUTE WEAR/ FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080385 ↗