n.a. 27050XBRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551078167), received between Jun 28, 2019 and Jan 7, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED DURING A TURP BIOPSY PROCEDURE ON (B)(6) 2024, THERE WAS A BREAKAGE OF THE CERAMIC. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED, THE DOCTOR WAS ABLE TO REMOVE THE BROKEN PIECE FLOATING AROUND AND THERE WAS A SURGAL DELAY OF APPROXIMATELY 25 MINUTES WHILE ATTEMPTING TO REMOVE THE BROKEN PIECES. HOWEVER, IT WAS REPORTED THAT IT'S HARD TO TELL IF THE BROKEN PIECE MAY HAVE CUT THE PATIENT ON THE WAY OUT.

  Patient problems: Insufficient Information

  MAUDE report 21092143 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED DURING A TURP BIOPSY PROCEDURE ON (B)(6) 2024, THERE WAS A BREAKAGE OF THE CERAMIC. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED, THE DOCTOR WAS ABLE TO REMOVE THE BROKEN PIECE FLOATING AROUND AND THERE WAS A SURGAL DELAY OF APPROXIMATELY 25 MINUTES WHILE ATTEMPTING TO REMOVE THE BROKEN PIECES. HOWEVER, IT WAS REPORTED THAT IT'S HARD TO TELL IF THE BROKEN PIECE MAY HAVE CUT THE PATIENT ON THE WAY OUT.

  Patient problems: Insufficient Information

  MAUDE report 21092140 ↗
• MalfunctionJul 15, 2019Material Separation; Material Separation

  DURING OUR INVESTIGATION OF A COMPLAINT REGARDING AN INNER TUBE CERAMIC BEAK THAT BROKE OFF INTO A PATIENT, WE WERE INFORMED BY THE FACILITY THAT, ALLEGEDLY, THEY HAD PREVIOUS CASE DURING WHICH A PIECE OF THE INNER TUBE'S CERAMIC BEAK BROKE OFF INTO THE PATIENT; THE PROCEDURE WAS A RIGHT URETEROSCOPY, RIGHT RETROGRADE PYELOGRAM, LASER LITHOTRIPSY, ATTEMPTED URETERAL STENT INSERTION PROCEDURE. THE HOSPITAL STATED THAT THE SCRUB NURSE NOTICED THE BEAK WAS MISSING A PIECE; THE PATIENT WAS X-RAYED IMMEDIATELY AND THE BROKEN PIECE WAS SEEN IN THE BLADDER AND THE SURGEON RETRIEVED IT DURING THE SAME PROCEDURE. THEY REPORTED THERE WAS NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791511 ↗
• MalfunctionJun 28, 2019Material Separation; Material Separation

  ALLEGEDLY, A PORTION OF THE INNER TUBE'S CERAMIC BEAK BROKE DURING A TURBT PROCEDURE; THE BROKEN PIECE WAS SUBSEQUENTLY FOUND IN A SPECIMEN CUP BY THE LAB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8745298 ↗