BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSACUT+ TISSUE MORCELLATOR

    MDR report key: 4610622 · Received March 17, 2015

    Report

    Report Number
    3004135191-2015-00018
    Event Type
    Death
    Date Received
    March 17, 2015
    Date of Event
    February 17, 2015
    Report Date
    April 29, 2015
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GCJ
    PMA / PMN Number
    K133272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED PATIENT DEATH CONTACTING THE USER FACILITY RISK MANAGER AND TREATING SURGEON DIRECTLY TO REQUEST PATIENT RECORDS, PATIENT CONTRIBUTORY PREEXISTING CONDITION INFORMATION AND ANY AUTOPSY CONCLUSIONS. THE PATIENT'S PRE-SURGICAL, SURGICAL, AND POST-SURGICAL RECORDS WERE PROVIDED TO LUMENIS. A REVIEW OF THE PATIENT'S PRE-SURGERY VISIT RECORD NOTED THE TREATING SURGEON STATED THE PATIENT WAS AN ACTIVE (B)(6) MALE WHO COMPLAINED OF SEVERELY SYMPTOMATIC URINARY SYMPTOMS. A REVIEW OF THE SUBJECT SURGICAL RECORD NOTED THE ENLARGED PROSTATE TISSUE WAS ENUCLEATED "WITHOUT DIFFICULTY." FURTHER THE TREATING SURGEON REPORTED THAT, "THE ENUCLEATED ADENOMAS WERE THEN MORCELLATED IN THE STANDARD MANNER USING THE [LUMENIS VERSACUT+ TISSUE] MORCELLATOR. A RESECTOSCOPE WAS USED TO RESECT THE FINAL "BEACHBALL" ADENOMAS WHICH WOULD NOT ENGAGE WITH THE MORCELLATOR. THE BLADDER MUCOSA WAS INJURED OVER THE RIGHT URETERAL ORIFICE AND ALSO ON THE POSTERIOR WALL. THESE AREAS WERE GENTLY CAUTERIZED TO ACHIEVE HEMOSTASIS. FINAL HEMOSTASIS WAS EXCELLENT". DURING A TELEPHONE CONVERSATION WITH THE TREATING PHYSICIAN, THE PHYSICIAN STATED THE LUMENIS LASER DID NOT MALFUNCTION. THE PHYSICIAN ALSO STATED THE PROCEDURE TOOK APPROXIMATELY TEN (10) HOURS TO COMPLETE AS A RESULT OF THE LARGE (~200 GRAM) PROSTATE TISSUE MASS. THE PHYSICIAN STATED THE "MORCELLATION WAS DIFFICULT". THE PHYSICIAN STATED THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THE PATIENT WAS REPORTEDLY PREPARING TO LEAVE THE HOSPITAL THE FOLLOWING DAY, COLLAPSED IN THE HOSPITAL, AND SUBSEQUENTLY DIED. A REVIEW OF SUBJECT PRODUCT INSTALLATION RECORDS AND SERVICE RECORDS FOUND THE SUBJECT PRODUCT VERSACUT+ WAS INSTALLED WITHIN SIX MONTHS OF THE EVENT REPORT AND WAS FOUND TO MEET ALL MANUFACTURER PERFORMANCE SPECIFICATIONS AT THE TIME OF INSTALLATION. THE SUBJECT DEVICE WAS NOT RETURNED TO LUMENIS FOR EXAMINATION; THEREFORE NO POST PROCEDURAL PERFORMANCE TESTS OF THE SUBJECT VERSACUT+ TISSUE MORCELLATOR WERE PERFORMED. LUMENIS DETERMINED THE EVENT IS REPORTABLE BASED ON INFORMATION FROM THE DOCTOR THAT THE PROCEDURE WAS PROLONGED BEYOND THEIR EXPECTATION AND THE FACT THE PATIENT DIED FOLLOWING THE EXTENDED PROCEDURE. THIS MEDICAL DEVICE REPORT IS BEING FILED BECAUSE THE REPORT OF PERFORMANCE ISSUES WITH SUBJECT DEVICE HAND PIECE ARE SIMILAR TO ISSUES REPORTED IN EVENT REPORT 3004135191-2015-00026. NOT RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED PATIENT DEATH CONTACTING THE USER FACILITY RISK MANAGER AND TREATING SURGEON DIRECTLY TO REQUEST PATIENT RECORDS, PATIENT CONTRIBUTORY PREEXISTING CONDITION INFORMATION AND ANY AUTOPSY CONCLUSIONS. DESPITE REASONABLE ATTEMPTS TO OBTAIN THIS INFORMATION, IT WAS NOT PROVIDED. DURING A TELEPHONE CONVERSATION WITH THE TREATING PHYSICIAN, THE PHYSICIAN STATED THE LUMENIS LASER DID NOT MALFUNCTION. THE PHYSICIAN ALSO STATED THE PROCEDURE TOOK APPROXIMATELY TEN (10) HOURS TO COMPLETE AS A RESULT OF THE LARGE (~200 GRAM) PROSTATE TISSUE MASS. THE PHYSICIAN STATED THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THE PATIENT WAS REPORTEDLY PREPARING TO LEAVE THE HOSPITAL THE FOLLOWING DAY, COLLAPSED IN THE HOSPITAL, AND SUBSEQUENTLY DIED. A REVIEW OF SUBJECT PRODUCT INSTALLATION RECORDS AND SERVICE RECORDS FOUND THE SUBJECT PRODUCT LASER SYSTEM WAS INSTALLED WITHIN SIX MONTHS OF THE EVENT REPORT AND WAS FOUND TO MEET ALL MANUFACTURER PERFORMANCE SPECIFICATIONS AT THE TIME OF INSTALLATION. DESPITE LUMENIS' REASONABLE ATTEMPTS TO OBTAIN INFORMATION WITH WHICH TO DETERMINE WHETHER THE LUMENIS PRODUCT DEPLOYED DURING THE SUBJECT EVENT WAS A CONTRIBUTORY FACTOR OF THE PATIENT'S DEATH, LUMENIS WAS UNABLE TO OBTAIN THAT INFORMATION. LUMENIS DETERMINED THE EVENT IS REPORTABLE BASED ON INFORMATION FROM THE DOCTOR THAT THE PROCEDURE WAS PROLONGED BEYOND THEIR EXPECTATION AND THE FACT THE PATIENT DIED FOLLOWING THE EXTENDED PROCEDURE. LUMENIS IS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED PATIENT DEATH BASED ON THE INFORMATION PROVIDED. DEVICE WAS NOT MADE AVAILABLE.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A PATIENT DIED ONE DAY FOLLOWING A HOLE PROCEDURE DURING WHICH A LUMENIS POWER-SUITE LASER WAS DEPLOYED. ADDITIONALLY THE PROCEDURE WAS REPORTED TO HAVE TAKEN TEN (10) HOURS FROM START TO COMPLETION.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT A PATIENT DIED ONE DAY FOLLOWING A HOLEP PROCEDURE DURING WHICH A LUMENIS VERSACUT+ TISSUE MORCELLATOR WAS DEPLOYED TO REMOVE THE RESECTED PROSTATE TISSUE. ADDITIONALLY THE PROCEDURE WAS REPORTED TO HAVE TAKEN TEN (10) HOURS FROM START TO COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180863 VERSACUT+ TISSUE MORCELLATOR SOFT TISSUE MORCELLATOR AND ACCESSORIES GCJ LUMENIS, LTD. VERSACUT+ TISSUE MORCELLATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death