TULSA-PRO 109171Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07540281001370), received between Jun 9, 2023 and Jun 9, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2023Difficult to Insert; Difficult to Insert

  ON (B)(6) 2023, PATIENT UNDERWENT A PROSTATE ABLATION PROCEDURE WITH THE TULSA-PRO TRANSURETHRAL ULTRASOUND ABLATION SYSTEM. THE PROCEDURE INVOLVES INSERTION OF AN ENDORECTAT COOLING DEVICE (ECD) FOR PASSIVE COOLING OF THE RECTUM DURING THE ABLATION PROCEDURE. THE TREATING UROLOGIST REPORTED THAT DURING DEVICE INSERTION, INITIAL IMAGING REVEALED THAT THE ECD WAS NOT PROPERLY INSERTED AND AN ADJUSTMENT WAS REQUIRED TO INSERT THE DEVICE FURTHER INWARDS. THE UROLOGIST REPORTED THAT SHE FELT RESISTANCE DURING THE INSERTION BUT EVENTUALLY WAS CAPABLE TO PUSH THE DEVICE FURTHER INSIDE THE BODY. SUBSEQUENT MR IMAGES, SHOWED THE PROPER PLACEMENT OF THE ECD AND THE TEAM PROCEEDED WITH THE ULTRASOUND TREATMENT OF THE PROSTATE WITH NO UNUSUAL ISSUES RELATED TO RECTAL COOLING. THE FOLLOWING DAY ((B)(6) 2023), PATIENT REPORTED PAIN IN HIS STOMACH. FOLLOW-UP CT IMAGES REVEALED RECTAL PERFORATION BEYOND THE TREATMENT AREA WHERE THE ECD TIP ENDS. THE RADIOLOGIST SUSPECTS THAT THIS PERFORATION HAS HAPPENED DUE TO THE MECHANICAL DAMAGE DONE BY THE EXCESSIVE INSERTION OF THE ECD. RADIOLOGIST MENTIONED THAT THE PATIENT HAD PREVIOUS PROSTATE RADIATION THERAPY AND THEREFORE HIS RECTAL TISSUE COULD BE VU

  Patient problems: Perforation

  MAUDE report 17101694 ↗