PIRANHA 49700113Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207063422), received between Jul 18, 2024 and Jul 18, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Misassembly by Users” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2024Misassembly by Users; Misassembly by Users

  RICHARD WOLF GMBH HAS BEEN INFORMED OF AN ISSUE REGARDING A ROTATIONS-MORCELLATOR Ø 4.8MM WL 335MM, PART ID: 49700113, LOT# UNKNOWN. ACCORDING TO THE RECEIVED INFORMATION, A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE AND MORCELLATION WAS PLANNED. FOR THIS PURPOSE, A POWER CONTROL 2303 (RICHARD WOLF), PIRANHA CONTROL 2208 (RICHARD WOLF), PIRANHA HANDPIECE (RICHARD WOLF) AND A HOLEP NEPHROSCOPE SYSTEM FROM KARL STORZ WAS PROVIDED IN THE OPERATING THEATRE. WHEN USING THE HOLEP NEPHROSCOPE SYSTEM FROM KARL STORZ, THE PIRANHA BLADE VMAX ROTARY MORCELLATOR 49700103 (RICHARD WOLF) MUST BE USED. INSTEAD, A RICHARD WOLF INSTRUMENTS, PIRANHA BLADE VMAX ROTATION MORCELLATOR, 49700113 WERE SUPPLIED. THE RICHARD WOLF BLADE SUPPLIED IS NOT COMPATIBLE FOR KARL STORZ INSTRUMENTS. THE ENUCLEATION WAS COMPLETED. HOWEVER, THE MORCELLATION WAS UNABLE TO BE COMPLETED, BECAUSE THE INCORRECT SIZE MORCELLATOR BLADE (49700113) WAS APPLIED. THERE WAS NO REPORTED HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED 10-DAYS LATER UNDER A SECOND GENERAL ANESTHETIC SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19773010 ↗