BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM

    MDR report key: 6165552 · Received December 11, 2016

    Report

    Report Number
    3004135191-2016-00043
    Event Type
    Death
    Date Received
    December 11, 2016
    Date of Event
    December 3, 2016
    Report Date
    January 9, 2017
    Manufacturer
    LUMENIS, LTD
    Product Code
    GEX
    PMA / PMN Number
    K050639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS HAS JUST BECOME AWARE OF THIS REPORTED EVENT AND IS CURRENTLY INVESTIGATING. A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    LUMENIS CONTACTED THE FOREIGN USER FACILITY THROUGH THE DISTRIBUTOR TO INVESTIGATE THE REPORTED EVENT. PATIENT INFORMATION AND A PHYSICIAN REPORT OF THE REPORTED EVENT WERE PROVIDED FROM THE USER FACILITY, INCLUDING SERVICE RECORDS OF THE SUBJECT DEVICES PROVIDED BY THE DISTRIBUTOR. A REVIEW OF THE SUBJECT DEVICES HISTORY RECORDS (DHR) DETERMINED THAT THE SUBJECT DEVICES WERE MANUFACTURED AND TESTED ACCORDING TO MANUFACTURE SPECIFICATIONS. A REVIEW OF SERVICE RECORDS SHOWED THAT THE SUBJECT DEVICES HAVE HAD THEIR ANNUAL PREVENTATIVE MAINTENANCE PERFORMED BY A LUMENIS-CERTIFIED SERVICE ENGINEER (06-OCT-2016), AND THE DEVICES HAVE MET CALIBRATION SPECIFICATIONS AND CONFIGURATIONS ESTABLISHED BY THE MANUFACTURER, AND ARE BOTH SAFE TO USE. A REVIEW OF SERVICE RECORDS FROM A FOLLOW-UP PREVENTATIVE MAINTENANCE (16-DEC-2016) PERFORMED BY A LUMENIS-CERTIFIED SERVICE ENGINEER SHOW THAT THE DEVICES HAVE MET CALIBRATION SPECIFICATIONS AND CONFIGURATIONS ESTABLISHED BY THE MANUFACTURER, AND ARE BOTH SAFE TO USE. A REVIEW OF SUBJECT DEVICES LABELING (0631-060-01 - VERSACUT OP MANUAL) STATED THE FOLLOWING: "BLADE SETS HAVE A LIMITED REUSE OF APPROXIMATELY 2-8 TIMES, DEPENDING UPON THE SIZE AND CONSISTENCY OF THE TISSUE MORCELLATED ". IT WAS REPORTED THAT THE DEVICE OPERATOR WAS USING BLADES WHICH HAD BEEN REPROCESSED 17 (SEVENTEEN) TIMES, AND WHEN THE BLADES FAILED TO MORCELLATE TISSUE, RATHER THAN SWITCH TO NEW STERILE BLADES WHICH WERE IN THE OPERATING ROOM THE OPERATOR HAD SWITCHED TO A TURP PROCEDURE. LUMENIS CONCLUDED THAT DEVICE OPERATOR FAILURE TO FOLLOW SUBJECT DEVICE IFU AND COMMON MEDICAL PRACTICE TO BE THE DETERMINED PROBABLY CAUSE OF THE REPORTED EVENT. EVALUATED BY CERTIFIED SERVICE ENGINEER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A FOREIGN DISTRIBUTOR THAT FOLLOWING A HOLEP PROCEDURE WITH A LUMENIS VERSAPULSE POWERSUITE 100W LASER THE PATIENT SUBSEQUENTLY DIED. IT WAS FURTHER REPORTED THAT THE HOLEP PROCEDURE WAS CONVERTED TO A TURP PROCEDURE.

    Description of Event or Problem · 1

    ON DECEMBER 12, 2016, LUMENIS RECEIVED AN INCIDENT REPORT, FILLED OUT BY THE PHYSICIAN/OPERATOR OF THE DEVICE, WHICH STATED: "ACCORDING TO AN ULTRASOUND DONE IN (B)(6) 2016 THE PROSTATE SIZE WAS ESTIMATED TO BE 112G, AND DESPITE THE OPEN BLADDER NECK AND ONE BLADDER STONE (~61MM) ALL INDICATIONS POINTED TO A HOLEP PROCEDURE. SURGERY DONE ACCORDING TO PROTOCOL, PROSTATE REMOVED IN THREE SEGMENTS. THERE WERE MANY SMALL INTRAPROSTATIC CALCIFICATIONS OF 2MM IN THE DIRECTION OF THE CAPSULE OF THE PROSTATE, WHICH WERE DIFFICULT TO REMOVE, BUT DONE WITHOUT ANY CAPSULAR RUPTURE. THIS STAGE OF THE SURGERY BEGAN AT 8:30 AND ENDED AT NOON. WE STARTED PERFORMING THE MORCELLATION AND WENT WELL ON THE FIRST LASER ONLY. WE RETURNED WITH THE LASER TO CUT THE LOBE, BUT AGAIN THE MORCELLATION DIDN'T WORK WELL. TURP WAS CHOSEN, AND IN THE END THERE WAS A GAS EXPLOSION WITH BLADDER RUPTURE AND ABDOMINAL DISTENSION. THE ANESTHESIOLOGIST REPORTED WORSENING LUNG FUNCTION AND OPENED THE ABDOMINAL CAVITY. AND ASPIRATED THE ABDOMINAL FLUID CONTENTS WITH IMMEDIATE CLINICAL IMPROVEMENT AND PERFORMED THE BLADDER ??? SUCCESSFULLY. AFTER REMOVE OF THE FRAGMENTS THE URINE WAS CLEAR. THE WEIGHT OF THE PROSTATE REMOVED WEIGHT 160G. AFTER 1 HOUR THERE WAS A DROP IN BLOOD PRESSURE AND A DIAGNOSIS OF ACUTE MYOCARDIAL INFARCTION WAS MADE. CATHETERIZATION AND DILUTION OF ANTERIOR DESCENDING STENOSIS (80% OBSTRUCTION) WERE PERFORMED WITHOUT STENT SUCCESS. UNFORTUNATELY WHEN ARRIVED AT CTI (ICU) THE PATIENT WAS WITH MYDRIASIS AND DIED AT 9:10 AM THE FOLLOWING DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816272 LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM SOFT TISSUE MORCELLATOR GEX LUMENIS, LTD VERSACUT MORCELLATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death