Versacut Tissue MorcellatorRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07290109140681), received between Feb 5, 2019 and Aug 26, 2024 — classified as 1 death, 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, THE DEVICE WAS NOT WORKING PROPERLY, SINCE IT CANNOT CUT THE TISSUE. THE PROCEDURE WAS NOT COMPLETED, AND IT WAS FINISHED UNTIL THE NEXT DAY AFTER THE CONSOLE WAS CHECKED. THE PATIENT WAS UNDER GENERAL ANESTHESIA, HOWEVER, THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063978 ↗
• MalfunctionAug 14, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE MORCELLATOR COULD NOT BE ACTIVATED DURING FIRST USE. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS SEDATED WITH GENERAL ANESTHESIA, PRIOR TO CANCELLING THE PROCEDURE. HOWEVER, THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987037 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN THE INTERNATIONAL JOURNAL OF UROLOGY THAT A STUDY WAS CONDUCTED TO EXAMINE THE DETECTION RATE OF INCIDENTAL PROSTATE CANCER BY HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) AND VARIABLES ASSOCIATED WITH THEM. THE PROCEDURE WAS PERFORMED USING THE LUMENIS VERSACUT MORCELLATOR SYSTEM. THE DATA OF 612 PATIENTS WHO UNDERWENT A HOLEP PROCEDURE BETWEEN JULY 2013 AND SEPTEMBER 2021 WERE RETROSPECTIVELY REVIEWED. POSTOPERATIVELY, URINARY TRACT INFECTION, HEMATURIA, URINARY RETENTION, AND PERFORATION OF BLADDER OR PROSTATE WERE SEEN IN 32, 22, 15, AND 6 CASES, RESPECTIVELY FOR 3 DAYS OF POSTOPERATIVE HOSPITALIZATION.

  Patient problems: Hematuria; Perforation; Urinary Retention; Urinary Tract Infection

  MAUDE report 19536609 ↗
• MalfunctionOct 23, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT, DURING THE PROCEDURE, THE BLADE AT THE END OF THE HANDPIECE DID NOT ROTATE. THE BLADE WAS REPLACED, AND THE CONSOLE WAS TURNED RESTARTED, BUT THE ISSUE DID NOT RESOLVE. THE PROCEDURE WAS NOT COMPLETED DUE TO REPORTED ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993042 ↗
• MalfunctionMay 18, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT WHEN THE DEVICE WAS INSERTED INTO THE PATIENT BLADDER, THE PHYSICIAN REALIZED THAT VERSACUT DEVICE WAS NOT WORKING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS REPORTED. AFTER THAT, IT WAS NOTIFIED BY ADDITIONAL INFORMATION THAT A REPLACEMENT UNIT WAS SENT DUE TO THE UNIT IS UNDER WARRANTY. THIS EVENT IS BEING REPORTED FOR A CANCELLED/RESCHEDULED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16957580 ↗
• InjuryMar 15, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE, THE VERSACUT BLADE BROKE OFF. THE FRAGMENT WAS COMPLETELY RECOVERED FROM THE PATIENT S BODY. THERE WAS NO PATIENT ADVERSE EFFECT DUE TO THE BLADE BREAK. IT WAS NOTED THAT THERE WERE NO ABNORMALITIES IDENTIFIED IN THE APPEARANCE OF THE VERSACUT PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544087 ↗
• InjuryNov 18, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THIS MORCELLATOR STOPPED DURING A PROCEDURE DUE TO A FOOTSWITCH ISSUE. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR A CANCELLED/RESCHEDULED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825686 ↗
• InjuryMay 23, 2021Use of Device Problem; Use of Device Problem

  LUMENIS RECEIVED FROM (B)(6), ADVERSE INCIDENT REPORT (REF: (B)(4)), FROM (B)(6) HOSPITALS (B)(6) CONCERNING THE VERSACUT TISSUE MORCELLATOR. IT READS: "THE HAND PIECE WAS CONNECTED TO THE WRONG SIDE OF THE PUMP, THIS IS BEING RAISED AS A POTENTIAL USER INTERFACE PROBLEM." THERE WAS NO INJURY. "THE USER HAS ADDED THEIR OWN LABEL TO HELP ENSURE CORRECT ORIENTATION OF CONNECTION". UPDATE 28-APR-2021 PATIENT ARRIVED IN THEATRE FOR A HOLEP PROCEDURE. THE SCRUB NURSES AND THE CIRCULATING NURSE CONNECTED THE MORCELATOR TUBING AND TESTED IT. THE CIRCULATING NURSE REMEMBERS CHECKING IT THE MACHINE WITH THE TUBING IN PLACE AND EVERYTHING WAS WORKING APPROPRIATELY. AFTER 30 SECONDS TO A MINUTE WHEN SURGEON STARTED THE MORCELLATING PROCESS THEY REALISED THAT THE PROSTATE CHIPS WERE GOING UP THE GIVING SET AS THE MACHINE WAS BLOWING AIR INTO THE PATIENT INSTEAD OF SUCKING THE FLUID OUT OF THE PATIENT. THEY CHANGED IMMEDIATELY THE TUBING INTO THE MORCELATOR MACHINE. AFTER ANOTHER 10 MINUTES PATIENT ARRESTED, THE PROCEDURE WAS STOPPED. AFTER CONNECTING THE TUBING INTO THE MORCELATOR MACHINE THE SCRUB NURSE AND THE CIRCULATING NURSE CHECKED THE POSITION OF THE TUBING BY IMMERSING THE MORCELLATOR

  Patient problems: Cardiac Arrest

  MAUDE report 11868490 ↗
• MalfunctionApr 13, 2021Break; Break

  A FOREIGN USER FACILITY REPORTED THAT DURING A HOLEP PROCEDURE IN WHICH A LUMENIS VERSACUT MORCELLATOR WAS BEING UTILIZED, THE MORCELLATOR STOPPED WORKING, WHILST EXCHANGING IT OUT, METAL WAS SEEN IN THE PATIENT BLADDER, THIS WAS REMOVED AND FOUND TO BE THE END RING OFF THE MORCELLATOR, THAT IS PART OF THE BLADE. THE HAND PIECE AND BLADE WERE REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655197 ↗
• MalfunctionFeb 5, 2020Break; Break

  A USER FACILITY REPORTED THAT AFTER A HOLEP PROCEDURE IN WHICH A LUMENIS VERSACUT MORCELLATOR WAS BEING UTILIZED, THE PHYSICIAN REMOVED THE BLADE OF THE MORCELLATOR AND FOUND THAT THE TIP WAS MISSING FROM THE MORCELLATOR BLADE. AN X-RAY REVEALED THAT THE METAL PIECES WERE IN THE PATIENT'S BLADDER AND THE PHYSICIAN WAS ABLE TO RETRIEVE THE PIECES. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9669700 ↗
• MalfunctionNov 18, 2019Break; Break

  A FOREIGN USER FACILITY REPORTED THAT ON (B)(6) 2019 DURING A HOLEP PROCEDURE IN WHICH A LUMENIS VERSACUT MORCELLATOR WAS BEING UTILIZED,"DURING THE MORCELLATION IT WAS NOTED THE PROCEDURE WAS NOT AS EFFECTIVE AS NORMAL. INVESTIGATION REVEALED THE TIP WAS MISSING FROM THE MORCELLATOR BLADE. THE TIP LOCATED AND REMOVED FROM THE PATIENT. DUE TO THE EXTENDED TIME THE PATIENT WAS UNDER THERE WAS INCREASED FLUID RETENTION." NO DIRECT COMPLICATIONS CAME FROM THE FAILURE OF THE BLADE, HOWEVER THE PATIENT WAS "BLUE-LIGHTED TO A HOSPITAL WITH ICU FACILITIES WHERE THE PATIENT WAS ADMINISTERED DRUGS TO EXPEL EXCESS FLUIDS". IT WAS FURTHER REPORTED THAT PATIENT HAS FULLY RECOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9334321 ↗
• MalfunctionMay 1, 2019Suction Problem; Suction Problem

  A FOREIGN DISTRIBUTOR REPORTED THAT ONE OF ITS CUSTOMERS ALLEGED PERFORMANCE ISSUES DURING USE OF THEIR LUMENIS VERSACUT MORCELLATOR SYSTEM. THE CUSTOMER ALLEGED ISSUES WITH "SUCTION NOT (BEING) TRUSTABLE" DURING THE MORCELLATION PART OF HOLEP PROCEDURES AND AS A RESULT THERE HAVE BEEN "SOME ACCIDENTS WITH BLADDER INJURIES". THE CUSTOMER FURTHER ALLEGED THAT "WHEN THE PROBLEM OCCURS DURING PROCEDURES THEY CHANGE THE TUBING AND BLADES. SOMETIMES THEY CANNOT DO THE MORCELLATION PROCEDURE AT ALL AND THE PATIENT HAS TO COME BACK FOR ANOTHER OPERATION IN THE FOLLOWING DAYS, OR THEY TRIED TO MINIMIZE THE TISSUE WITH BIPOLAR RESECTION."

  Patient problems: No Known Impact Or Consequence To Patient; Perforation

  MAUDE report 8567802 ↗
• MalfunctionMay 1, 2019Loose or Intermittent Connection; Suction Problem; Loose or Intermittent Connection; Suction Problem

  A FOREIGN DISTRIBUTOR REPORTED THAT ONE OF ITS CUSTOMERS ALLEGED PERFORMANCE ISSUES DURING USE OF THEIR LUMENIS VERSACUT MORCELLATOR SYSTEM. THE CUSTOMER ALLEGED ISSUES WITH "SUCTION NOT (BEING) TRUSTABLE" DURING THE MORCELLATION PART OF HOLEP PROCEDURES AND AS A RESULT THERE HAVE BEEN "SOME ACCIDENTS WITH BLADDER INJURIES". THE CUSTOMER FURTHER ALLEGED THAT "WHEN THE PROBLEM OCCURS DURING PROCEDURES THEY CHANGE THE TUBING AND BLADES. SOMETIMES THEY CANNOT DO THE MORCELLATION PROCEDURE AT ALL AND THE PATIENT HAS TO COME BACK FOR ANOTHER OPERATION IN THE FOLLOWING DAYS, OR THEY TRIED TO MINIMIZE THE TISSUE WITH BIPOLAR RESECTION."

  Patient problems: No Known Impact Or Consequence To Patient; Perforation

  MAUDE report 8567800 ↗
• DeathMar 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A FOREIGN USER FACILITY REPORTED THAT DURING A HOLEP PROCEDURE IN WHICH A LUMENIS VERSACUT MORCELLATOR WAS BEING UTILIZED, "AFTER 5-10 GRAMS OF MORCELLATION, NO MORE MORCELLATION COULD BE ACCOMPLISHED." ALLEGEDLY THE TISSUE BEING MORCELLATED WAS EXTREMELY HARD AND THEREFORE UNABLE TO ENTER INTO THE APERTURE OF THE BLADES. THE FACILITY SWITCHED TO AN OPEN SURGERY TO GET INTO THE PATIENT'S BLADDER AND MANUALLY REMOVE THE TWO ENUCLEATED LOBES. DURING THAT OPEN SURGERY, THE PATIENT BEGAN TO BLEED UNCONTROLLABLY AND WAS MOVED TO ICU. THE PATIENT REPORTEDLY DIED THE FOLLOWING DAY.

  Patient problems: Death

  MAUDE report 8427250 ↗
• InjuryFeb 5, 2019Backflow; Backflow

  A FOREIGN USER FACILITY REPORTED THAT ON (B)(6) 2019 DURING A HOLEP PROCEDURE IN WHICH A LUMENIS VERSACUT MORCELLATOR WAS BEING UTILIZED TO REMOVE PROSTATE TISSUE FROM A PATIENT, THE DOCTOR NOTICED THAT THE PATIENT'S VITAL SIGNS REACHED A CRITICAL LEVEL. IT HAD BEEN OBSERVED THAT THE VERSACUT HANDPIECE WAS NOT 'ASPIRATING EFFECTIVELY'. UPON CHECKING THE SYSTEM, IT WAS FOUND THAT THE HANDPIECE WAS IMPROPERLY PREPARED; THE SUCTION TUBING HAD INADVERTENTLY BEEN SET-UP IN THE OPPOSITE DIRECTION CAUSING THE FLOW TO BE REVERSED. THE TUBING WAS RESET IN THE CORRECT MANNER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ALTHOUGH THE VITAL SIGNS OF THE PATIENT SHOWED SIGNS OF IMPROVEMENT AFTER THE MORCELLATION WAS COMPLETED, THE PATIENT REMAINED UNCONSCIOUS AND WAS MOVED TO THE ICU WHERE HE REMAINED UNCONSCIOUS FOR FIVE DAYS. IT WAS LATER REPORTED ON 30-JAN-2019 BY THE FACILITY'S 'HOSPITAL OFFICER' THAT ALTHOUGH THE PATIENT HAD REGAINED CONSCIOUSNESS, THE PATIENT WAS SHOWING DIFFICULTY IN 'MOVING HIS BODY AND COMMUNICATION'. THE OFFICER FURTHER NOTED THAT THESE PROGNOSTIC SYMPTOMS MIGHT REMAIN DUE TO HYPOXIA. TO THE BEST OF LUMENIS' KNOWLEDGE, THE PATIENT STILL REMAINS HOSPITALIZED AT THE DAT

  Patient problems: Hypoxia

  MAUDE report 8303779 ↗