BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSACUT TISSUE MORCELLATOR

    MDR report key: 8427250 · Received March 17, 2019

    Report

    Report Number
    3004135191-2019-00030
    Event Type
    Death
    Date Received
    March 17, 2019
    Date of Event
    February 15, 2019
    Report Date
    June 6, 2019
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEI
    UDI-DI
    07290109140681
    PMA / PMN Number
    K050639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EQUIPMENT FROM THE REPORTING FACILITY WAS EVALUATED BY A LUMENIS SERVICE ENGINEER ON 17-APR-2019. VERSACUT CONSOLE (SN (B)(4) AND FOOTSWITCH. VERSACUT HANDPIECE (SN (B)(4). TWO BLADE SETS. INITIAL EVALUATION FOUND: BLADE SETS WERE VISUALLY EXAMINED. ONE 'OUTER PART' OF A BLADE SET WAS FOUND TO BE BENT/DAMAGED. ONE 'INNER PART' OF ONE BLADE SET (DETERMINED TO BE THE ONE USED DURING THE PROCEDURE) WAS FOUND TO BE CLOGGED WITH STONES. THE "INNER PART' OF A SECOND BLADE SET WAS OBSERVED TO BE NORMAL. TESTING OF HANDPIECE WITH 'GOOD BLADES': HANDPIECE (S0318) AND 'GOOD' BLADE SET WAS TESTED ON CONSOLE (1269). UPON INITIAL ACTIVATION OF THE FOOT PEDAL, ASPIRATION AND MORCELLATION WAS TESTED AND VERIFIED TO BE FUNCTIONAL WITH NO ISSUES FOUND. TESTING OF HANDPIECE WITH 'CLOGGED' BLADES: HANDPIECE (S0318) AND 'CLOGGED' BLADE SET WAS TESTED ON CONSOLE (1269). UPON ACTIVATION OF THE FOOT PEDAL, ALL LEVELS OF ASPIRATION WERE FOUND TO BE INADEQUATE. A REVIEW OF SUBJECT DEVICE VERSACUT OPERATOR'S MANUAL (0631-060-01_ G) REVEALED THE FOLLOWING IN THE TROUBLESHOOT SECTION: "THERE IS NO VISIBLE FLOW OF FLUID OR TISSUE IN THE ASPIRATION TUBING" PROBABLE CAUSE : THE BLADE CHANNEL IS CLOGGED. SUGGESTION : REMOVE THE OUTER BLADE FROM THE HANDPIECE. WIPE THE OUTER SURFACE OF THE INNER BLADE WITH A SOFT GAUZE CLOTH TO ENSURE THAT IT IS CLEAN OF ANY TISSUE OR DEBRIS. REMOVE THE INNER BLADE FROM THE HANDPIECE, AND CHECK FOR VISIBLE SIGNS OF BLOCKAGE. IF NECESSARY, RUN A GUIDE WIRE THROUGH THE INNER BLADE CHANNEL TO CLEAR THE OBSTRUCTION. VERIFY THAT THE BLOCKAGE IS CLEARED BY INSERTING THE INNER BLADE, WITH ASPIRATION TUBING ATTACHED, INTO A BOWL OF STERILE SOLUTION AND DEPRESSING THE FOOTSWITCH SLIGHTLY TO INITIATE ASPIRATION. WHEN THE BLOCKAGE IS CLEARED, RECONNECT THE INNER AND OUTER BLADES TO THE HANDPIECE AND RESUME NORMAL OPERATION. IT HAD BEEN REPORTED THAT THE DEVICE OPERATOR WAS USING 'CLOGGED' BLADES DURING THE PROCEDURE, AND WHEN THE BLADES FAILED TO ASPIRATE AND MORCELLATE TISSUE, RATHER THAN TRY TO CLEAR THE BLOCKAGE OR SWITCH TO AN ALTERNATE BLADE SET, THE OPERATOR SWITCHED TO AN OPEN PROCEDURE. LUMENIS CONCLUDED THAT DEVICE OPERATOR FAILURE TO FOLLOW SUBJECT DEVICE IFU MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE FACILITY HAS SINCE BEEN REMINDED HOW TO TROUBLESHOOT POOR ASPIRATION OR WEAK MORCELLATION.

    Additional Manufacturer Narrative · 1

    LUMENIS MADE REASONABLE ATTEMPTS TO CONTACT THE DISTRIBUTOR THROUGH ITS FOREIGN SUBSIDIARY IN ORDER TO HELP OBTAIN ADDITION INFORMATION REGARDING THE REPORTED EVENT; DESPITE REASONABLE ATTEMPTS, VERY LITTLE ADDITIONAL INFORMATION HAD BEEN PROVIDED BESIDES THE INCIDENT FORM. A REVIEW OF THE SUBJECT DEVICE DHR CONFIRMED THAT THE SUBJECT DEVICE WAS MANUFACTURED AND TESTED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, AND SHIPPED ACCORDING TO MANUFACTURER'S SPECIFICATIONS. MANUFACTURE DATE: 26-OCT-2017. A REVIEW OF THE INCIDENT FORM REVEALED 400 GRAMS OF PROSTATE WAS ENUCLEATED IN 2 HOURS PRIOR TO BEGINNING THE MORCELLATION. AFTER 20 GRAMS OF MORCELLATION, THE VERSACUT ALLEGEDLY COULD NOT CONTINUE MORCELLATING DUE TO DENSE TISSUE. THE OPERATOR PROCEEDED TO REMOVE THE ENUCLEATED LOBES THROUGH OPEN SURGERY. DURING OPEN SURGERY, THE PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS AND WAS TRANSFERRED TO ANOTHER MEDICAL FACILITY. A LUMENIS SERVICE MANAGER REPORTED THAT "BECAUSE THE MORCELLATOR [?]DID NOT WORK' (MORCELLATE TOUGH TISSUE) THEY HAD TO TAKE OUT THE MORCELLATOR AND SURGICALLY REMOVE THE PROSTATE. IN THE PROCESS SOMETHING HAPPENED AND PATIENT STARTED BLEEDING, AND YESTERDAY ((B)(6) 2019) THE PATIENT DIED." A REVIEW OF SUBJECT DEVICE RISK FILES (RISK #(B)(4)) REVEALED THE RISK OF "TISSUE MORCELLATION DIFFICULTY DUE TO TOUGH TISSUE' RESULTING IN A PROLONGED PROCEDURE' " AS A KNOWN RISK. THE RISK CARRIES A HAZARD SEVERITY OF 2 (MINOR: POOR PERFORMANCE REQUIRING USE OF ALTERNATIVE PRODUCT). THE RISK HAS BEEN CHARACTERIZED AND DOCUMENTED AS ACCEPTABLE WITHIN FULL RISK ASSESSMENT. A LUMENIS CLINICAL DIRECTOR EVALUATED THE REPORTED EVENT AND DETERMINED THAT "IN CASES OF DENSE PROSTATIC TISSUE ADDITIONAL TIME IS SOMETIMES NEEDED TO TRY TO MORCELLATE THE ENUCLEATED TISSUE. IN CERTAIN CASES, THE MORCELLATOR CAN EFFECTIVELY WORK ON OTHER PARTS OF THE TISSUE, LEAVING JUST SMALL FRAGMENTS THAT WOULD NOT BE ABLE BE TO REMOVED. IN THE CASE OF NO ABILITY TO COMPLETE THE MORCELLATION, THE COMMON MEDICAL PRACTICE WOULD BE TO: OBTAIN ANOTHER ENERGY SOURCE THROUGH THE SAME WORKING CHANNEL (I.E., INSERT AN RF PROBE (TURP) / LASER FIBER) TO FURTHER BREAK DOWN OR MANIPULATE THE PROSTATIC TISSUE IN ORDER TO ALLOW MORE EFFECTIVE MORCELLATION WITH THE MORCELLATOR -OR- INSERT A RETRACTOR/GRASPER/BASKET THROUGH THE WORKING CHANNEL IN ORDER TO REMOVE THE REMAINING TISSUE MANUALLY. ONLY AFTER TRYING THESE COMMON MEDICAL CARE, SWITCHING TO OPEN SURGERY IS AN OPTION. LUMENIS HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. LUMENIS DOES NOT BELIEVE THERE HAS BEEN ENOUGH ATTEMPTS TO REMOVE THE TISSUE WITH THE WORKING MORCELLATOR, AND THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS OR OTHERWISE FAIL TO PERFORM AS INTENDED; THUS LUMENIS DOES NOT BELIEVE THERE WAS A MALFUNCTION IN THIS EVENT. LUMENIS WAS NOT MADE AWARE OF THE REASONS WHY THIS PROCEDURE PROCEEDED TO AN OPEN SURGERY. ALTHOUGH THIS PARTICULAR CASE RESULTED IN DEATH, LUMENIS DOES NOT BELIEVE A LUMENIS DEVICE IS THE CAUSE OR CONTRIBUTORY TO THE EVENT." IN CONCLUSION, LUMENIS HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. LUMENIS DOES NOT BELIEVE THERE IS ENOUGH INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS OR OTHERWISE FAIL TO PERFORM AS INTENDED; THUS LUMENIS DOES NOT BELIEVE THERE WAS A MALFUNCTION IN THIS EVENT. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS, HOWEVER IT IS EXPECTED TO BE RETURNED. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220494 VERSACUT TISSUE MORCELLATOR SOFT TISSUE MORCELLATOR AND ACCESSORIES GEI LUMENIS LTD. VERSACUT MORCELLATOR 07290109140681

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death