AquaBeam Scope SC2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B614SC20001), received between May 1, 2025 and May 1, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMay 1, 2025Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE PRIOR TO THE PROCEDURE AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THAT THE AQAUBEAM SCOPE WAS BROKEN IN HALF AND COULD NOT BE USED. SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943995 ↗