n.a. 27040XBRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04048551076569), received between Apr 14, 2017 and Aug 15, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING TRANSURETHRAL WATERJET ABLATION OF PROSTATE PROCEDURE THE BEAK BROKE OFF. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817544 ↗
• MalfunctionApr 12, 2022Break; Material Separation; Break; Material Separation

  DURING A TURP, SURGEON COMPLETED THE SURGERY, AND REALIZED WHEN PULLING OUT THE INSTRUMENTS THAT A BROKEN PIECE OF CERAMIC CAME OUT. A MISSING PIECE IS STILL IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14084349 ↗
• MalfunctionNov 19, 2020Material Separation; Material Separation

  ALLEGEDLY, DURING A UROLOGY PROCEDURE, THE CERAMIC TIP OF THE SHEATH BROKE. THE PIECES WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10870740 ↗
• MalfunctionOct 16, 2019Break

  PER MEDWATCH REPORT, #MW5089606 RECEIVED ON (B)(6) 2019, IT WAS REPORTED THE "PLASTIC END PIECE OF INSTRUMENT BROKE DURING A PROCEDURE".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9200073 ↗
• MalfunctionMay 31, 2019Break

  PER MEDWATCH #MW5086564 WE RECEIVED, "PLASTIC TIP BROKE OFF DURING SURGERY, RETRIEVED BY SURGEON".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8660684 ↗
• MalfunctionApr 14, 2017Material Separation; Material Separation

  THIS IS A SUPPLEMENTAL. I AM ADDING THE DEVICE EVALUATION AND UPDATING CORRESPONDING FIELDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6494980 ↗
• MalfunctionApr 14, 2017Material Separation; Material Separation

  THIS IS A SUPPLEMENTAL REPORT. WE ARE PROVIDING EVALUATION OF DEVICE AND UPDATING OTHER FIELDS AS A RESULT. WE ARE CORRECTING DATE CODE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6494977 ↗