PIRANHA 49700103Recalls & reported problems
Richard Wolf GmbH · ROTATIONS-MORCELLATOR Ø 4.8MM WL 385MM for MORCESCOPE Storz, for morcellation following laser prostate enucleation, sterile · Class 2
All models of PIRANHA (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207063415), received between Sep 9, 2025 and Sep 9, 2025 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Suction Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Suction Failure; Suction Failure
IT WAS REPORTED THAT DURING THE HOLEP SURGERY, FOUR (4) MORCELLATOR BLADES FAILED TO ROTATE AND THEREFORE, UNABLE TO PROVIDE SUCTION. THE FIRST BLADE WORKED FOR 10 MINUTES THEN LOCKED UP AND THE BLADES AFTER THAT LOCKED UP AS WELL UPON TESTING THEM BEFORE INSERTING THEM INTO THE PATIENT. THE USER TRIED TO REPLACED THE TUBING AND THE CONTAINER, HOWEVER, FAILED TO GET THE BLADES TO FUNCTION. DUE TO THE REPORTED ISSUE, THE SCHEDULED PROCEDURE WAS CANCELLED AS WELL AS THE SUCCEEDING CASES. THERE WERE NO REPORTS OF INJURIES TO THE PATIENT OR THIRD PARTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23006566 ↗InjurySep 9, 2025Suction Failure; Suction Failure
IT WAS REPORTED THAT DURING THE HOLEP SURGERY, FOUR (4) MORCELLATOR BLADES FAILED TO ROTATE AND THEREFORE, UNABLE TO PROVIDE SUCTION. THE FIRST BLADE WORKED FOR 10 MINUTES THEN LOCKED UP AND THE BLADES AFTER THAT LOCKED UP AS WELL UPON TESTING THEM BEFORE INSERTING THEM INTO THE PATIENT. THE USER TRIED TO REPLACE THE TUBING AND THE CONTAINER, HOWEVER, FAILED TO GET THE BLADES TO FUNCTION. DUE TO THE REPORTED ISSUE, THE SCHEDULED PROCEDURE WAS CANCELLED AS WELL AS THE SUCCEEDING CASES. THERE WERE NO REPORTS OF INJURIES TO THE PATIENT OR THIRD PARTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23006460 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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