Trimedyne® OmniTip™ - 35 cm Side Firing Switchable Tip with Irrigation 20373-HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M47320373HP0), received between Jul 19, 2018 and Jul 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Discolored” (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 18, 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.

• MalfunctionJul 19, 2018Material Discolored; Melted; Overheating of Device; Material Separation; Use of Device Problem; Material Twisted/Bent; Material Discolored; Melted; Overheating of Device; Material Separation; Use of Device Problem; Material Twisted/Bent

  CUSTOMER STATED THAT THE 20471-HP WAS FUSED AND SHRUNK IN THE MIDDLE OF THE HANDPIECE WHEN IT WAS USED TOGETHER WITH 20371-HP. IT ONLY HAD A LITTLE ENERGY OUTPUT AFTER LASING LESS THAN 1 MINUTE. OUR QC FOUND IT IS STILL PASSING LIGHT. CUSTOMER STATED AT A LATER DATE "AFTER THE FIBER ASSEMBLY WAS CONNECTED TO THE EQUIPMENT, THE DOCTOR STEPPED ON THE PEDALS FOR LESS THAN 1 MINUTE. HE STOPPED USING THE CAMERA WHEN THE HANDLE HAD BEEN MELTED AND THE DOCTOR'S HAND WAS BURNT. THERE ARE NO PROBLEMS WITH CHECKING THE HANDLES AND EQUIPMENT." THIS INFORMATION IS DOCUMENTED AS REPORTED TO TRIMEDYNE, INC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7705173 ↗