PRINCESS 8653018Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207042861), received between Jul 22, 2020 and Feb 20, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Material Fragmentation

  IT WAS REPORTED THAT THE PLASTIC TIP OF THE INNER SHEATH, TYPE 8653.018, BROKE OFF DURING PROCEDURE (HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP)). THE BROKEN PIECES WERE SUCCESSFULLY RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400834 ↗
• MalfunctionJul 22, 2020Mechanical Problem; Mechanical Problem

  ON FEBRUARY 3RD, 2020, THE INITIAL REPORTER REACH OUT TO RWMIC AND REPORTED THAT DURING A PROCEDURE THE PLASTIC TIP BROKE INSIDE THE PATIENT. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10307623 ↗