PIRANHA 2030108Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207054734), received between Oct 16, 2020 and Oct 30, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Mechanical Problem; Suction Problem; Mechanical Problem; Suction Problem

  ACCORDING TO THE INFORMATION RECEIVED, A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) AND TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE WAS SCHEDULED. IT WAS REPORTED THAT DURING MORCELLATION, THE SUCTION FAILED ON ONE OF THE HANDPIECES. THE HANDPIECE WAS REPLACED, AND THE SUCTION IS WORKING. HOWEVER, WITH THE SECOND HANDPIECE, THE MORCELLATOR BLADE NO LONGER TURNED. THE BLADE WAS REPLACED 4 TIMES, WITHOUT SUCCESS. ALL ATTEMPTS TO TROUBLESHOOT, EVEN WITH GUIDANCE FROM A SERVICE TECHNICIAN, WERE UNSUCCESSFUL. DUE TO IT, THE SCHEDULED OPERATION WAS ABORTED. THE PATIENT MUST BE READMITTED WHEN THE DEVICE IS READY FOR USE AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 20566608 ↗
• MalfunctionSep 23, 2021Suction Failure; Suction Failure

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. PLEASE SEE MANUFACTURERS NARRATIVE.

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

  MAUDE report 12518826 ↗
• MalfunctionNov 6, 2020Overheating of Device; Overheating of Device

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE EVALUATION/INVESTIGATION. THE DEVICE WAS RECEIVED AND VISUALLY, FUNCTIONALLY AND ELECTRICALLY EVALUATED. THE REPORTED CONDITION WAS NOT CONFIRMED. THE DEVICE WAS CHECKED, NO ERRORS WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10803466 ↗
• MalfunctionOct 16, 2020Suction Problem; Suction Problem

  ON OCTOBER 5TH, 2020, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): PIRANHA HAND PIECE (SUCTION PUMP) KEPT FAILING TO ACTIVATE, TRIED RESTARTING UNIT BUT THE HAND PIECE WOULD NOT WORK. BRIEFLY SWITCHED TO ANOTHER HAND PIECE AND IT ONLY WORKED INTERMITTENTLY AS WELL. RESTARTED UNIT 5 TIMES, TOOK 3 HOURS TO DO A 30 MIN PROCEDURE. THE SHAVER HANDLE STOPS DURING PROCEDURE, THE UNIT SAYS TREATMENT MODE AND IS NOT EVACUATING WHEN IT STOPS. PLEASE CHECK FOOTSWITCH. THEY HAVE USED MULTIPLE SHAVER HANDLES IN ONE CASE AND THE SAME THING HAPPENED WITH DIFFERENT HANDLES. IT DELAYED THE PROCEDURE BY THREE HOURS, THE PATIENT HAD RECEIVED TWO BLOOD TRANSFUSIONS AS A RESULT. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? YES. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? (ONLY APPLICABLE IF THERE WAS A REPORT OF DELAY) YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE F

  Patient problems: Insufficient Information

  MAUDE report 10692993 ↗