BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACUT MORCELLATOR

    MDR report key: 2638689 · Received July 3, 2012

    Report

    Report Number
    3004135191-2012-00043
    Event Type
    Malfunction
    Date Received
    July 3, 2012
    Date of Event
    June 7, 2012
    Report Date
    August 15, 2012
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GCJ
    PMA / PMN Number
    K980079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURING SITE AND AN EVALUATION OF PERFORMANCE WAS COMPLETED BY A LUMENIS ENGINEER. THE LUMENIS ENGINEER FOUND THAT THE SUBJECT DEVICE MOTOR WAS STUCK AND WOULD NOT ROTATE BY HAND. THE ENGINEER NOTED THAT THE MOTOR ASSEMBLY O-RING WAS MISSING IN THE MOTOR HOUSING. ALL OTHER PERFORMANCE TESTS FOUND THE COMPONENTS OF THE SUBJECT DEVICE TO BE FUNCTIONING PROPERLY. THE ENGINEER CONCLUDED THE CAUSE OF THE MOTOR FAILURE TO BE HEATING OR MOISTURE FROM AUTOCLAVE STERILIZATION THAT PENETRATED THE MOTOR AS A RESULT OF THE MISSING O-RING. AN M.D. AND EXPERT IN HOLEP PROCEDURES EVALUATED THE REPORTED EVENT DETAILS CONCLUDING THAT, "IF THE HANDPIECE STOPS WORKING THEN THE PATIENT IS IN NO IMMEDIATE DANGER. THEY WILL HAVE TO HAVE A SECOND PROCEDURE TO REMOVE THE TISSUE OR A SMALL CYSTOTOMY (SMALL INCISION IN THE BLADDER) TO REMOVE THE TISSUE." ADDITIONALLY, THE M.D. STATED THAT, "OUR STANDARD OF PRACTICE IS TO ALWAYS TEST THE MORCELLATOR PRIOR TO THE START OF EACH PROCEDURE TO ENSURE THAT THIS DOES NOT OCCUR. AN ALTERNATIVE WOULD BE TO MAKE SURE THE HOSPITAL ALWAYS HAS A BACKUP UNIT IN WORKING ORDER." A REVIEW OF LABELING FOUND NO RELATED DEVIATIONS. A REVIEW OF RECORDS FOUND THAT NO SIMILAR EVENTS HAD BEEN REPORTED AND REVIEW OF RISK CONCLUDED THE EVENT IS WITHIN ACCEPTABLE STATISTICAL LIMITS. LUMENIS CONCLUDES THE ROOT CAUSE OF THE REPORTED EVENT (PATIENT REQUIRED A SECOND SURGERY TO COMPLETE THE HOLEP PROCEDURE) TO BE MANUFACTURING DEFICIENCY.

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE INITIAL REPORT CONTACTING THE DEVICE OPERATOR FOR FURTHER INFORMATION. THE DEVICE OPERATOR STATED THAT, "NO COMORBID CONDITIONS OF THE PATIENT'S CONTRIBUTED" TO THE EVENT REPORTED. THE CASE WAS REPORTED TO HAVE BEEN COMPLETED WITH NO SUBSEQUENT ADVERSE PATIENT EFFECT. THE SUBJECT DEVICE HAS BEEN SHIPPED TO THE MANUFACTURING SITE FOR EXAMINATION. LUMENIS WILL FILE A FOLLOW-UP MEDWATCH REPORT UPON COMPLETION OF THE EXAMINATION OF THE SUBJECT DEVICE AND DETERMINATION OF THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HOLEP PROCEDURE IN WHICH A LUMENIS VERSACUT MORCELLATOR WAS USED, THE SUBJECT DEVICE FAILED TO FUNCTION AS EXPECTED. THE DOCTOR REPORTED THAT THE MORCELLATOR HANDPIECE WOULD NOT RECIPROCATE THE BLADE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS RESCHEDULED FOR A SECOND SURGERY TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACUT MORCELLATOR COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES GCJ LUMENIS, LTD. VERSACUT MORCELLATOR HANDPIECE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention