BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACUT MORCELLATOR

    MDR report key: 2470151 · Received February 27, 2012

    Report

    Report Number
    3004135191-2012-00009
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    January 24, 2012
    Report Date
    February 27, 2012
    Manufacturer
    LUMENIS LTD
    Product Code
    GCJ
    PMA / PMN Number
    K050639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION WAS REPORTED OR SUSPECTED; THEREFORE, NO EVALUATION OF THE FUNCTION OF THE DEVICE OCCURRED. REASONABLE ATTEMPTS WERE MADE TO OBTAIN THE PATIENTS AGE RELEVANT PREEXISTING MEDICAL CONDITIONS AND THE CASE HISTORY FROM THE DEVICE OPERATOR HOWEVER NONE WERE RECEIVED. A LUMENIS MEDICAL DOCTOR AND EXPERT IN MORCELLATOR PROCEDURES CONCLUDED THAT INSUFFICIENT INFORMATION EXISTED TO DETERMINE TO DETERMINE THE CAUSE OF THE PATIENT'S REPORTED DECREASE IN BLOOD PRESSURE. A REVIEW OF SUBJECT DEVICE LABELING FOUND THAT THE OPERATOR MANUAL AND THE DEVICE ITSELF CLEARLY ILLUSTRATE AND DESCRIBE THE PROPER ROUTING OF THE VACUUM TUBE THROUGH THE PUMP HOUSING. ADDITIONALLY, THE PUMP HOUSING IS LABELED WITH THREE ARROWS TO GUIDE THE PREPARATION OF THE DEVICE PRIOR TO USE. THE ROOT CAUSE OF THE REPORT OF AIR INTRODUCTION TO THE TREATMENT SITE HAS BEEN DETERMINED TO BE OPERATOR ERROR; FAILURE ON THE PART OF THE DEVICE OPERATOR TO FOLLOW INSTRUCTIONS DESCRIBED IN THE SUBJECT DEVICE OPERATOR MANUAL AND DEVICE TRAINING TO PROPERLY CONNECT THE VACUUM TUBE PRIOR TO USE. THIS EVENT DOES NOT MEET THE REPORTING THRESHOLD FOR THE COUNTRY OF (B)(4); HOWEVER, LUMENIS IS FILING THIS MEDWATCH BASED ON THE REPORT THAT THE PATIENT WAS TRANSFERRED TO THE ICU FOR OBSERVATION POST-TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TUEB PROCEDURE A PATIENT SUSTAINED A DECREASE IN BLOOD PRESSURE AND INTRODUCTION OF AIR INTO THE BLADDER AS THE SURGEON BEGAN USING A LUMENIS VERSACUT MORCELLATOR. IT WAS FURTHER REPORTED THAT THE SURGEON NOTED THAT THE VACUUM TUBE OF THE MORCELLATOR WAS CONNECTED BACKWARD IN THE MORCELLATOR PUMP AND THAT THE PHYSICIAN CORRECTED THE VACUUM TUBING. IT WAS FURTHER REPORTED THAT THE PATIENT'S BLOOD PRESSURE STABILIZED AND THE PHYSICIAN COMPLETED THE TREATMENT WITH NO FURTHER ADVERSE OUTCOME. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE ICU FOR OBSERVATION. THE SURGEON REPORTED THAT THE PATIENT WAS EXAMINED POST TREATMENT AND FOUND TO HAVE SUSTAINED NO ADVERSE TREATMENT OUTCOME AS A RESULT OF THE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACUT MORCELLATOR ELECTRO SURGICAL CUTTING AND COAGULATION GCJ LUMENIS LTD VERSACUT MORCELLATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other