PIRANHA 41702208Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207054376), received between Jul 23, 2021 and Jan 3, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Suction Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2022Suction Failure; Suction Failure

  ON (B)(6) 2021, RICHARD WOLF (B)(4) WAS INFORMED IN DETAIL OF THE FOLLOWING INCIDENT: START OF MORCELLATION AFTER PROSTATE ENUCLEATION: AFTER A FEW SECONDS, THE MORCELLATOR SUCTION FAILS MORCELLATION IS NO LONGER POSSIBLE. REPLACEMENT OF ALL SYSTEM COMPONENTS WITHOUT FUNCTION RECOVERY; SUCTION TUBE COLLAPSES ABORTION OF THE PROCEDURE. 30 MINUTES SURGERY TIME EXTENSION. 2ND SURGERY TO REMOVE ADENOMAS FROM THE BLADDER. CONDITION OF THE PATIENT AFTER THE PROCEDURE: STABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142502 ↗
• InjuryDec 27, 2021Suction Failure; Suction Failure

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. SEE MANUFACTURERS NARRATIVE (H10).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13088189 ↗
• MalfunctionJul 23, 2021Collapse; Collapse

  SEE MANUFACTURER'S NARRATIVE FOR RESULTS OF THE DEVICE INVESTIGATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217083 ↗