BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACUT+ TISSUE MORCELLATOR

    MDR report key: 4883689 · Received July 1, 2015

    Report

    Report Number
    3004135191-2015-00049
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    February 12, 2015
    Report Date
    July 1, 2015
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GCJ
    PMA / PMN Number
    K133272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT, CONTACTING THE USER FACILITY DIRECTLY TO REQUEST FURTHER INFORMATION CONCERNING THE EVENT REPORT. A LOCAL LUMENIS SALES REPRESENTATIVE ALSO CONTACTED THE INITIAL REPORTER TO OBTAIN FURTHER INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURING SITE FOR TESTING AND EXAMINATION. LUMENIS TECHNICAL DESIGN AND QUALITY ENGINEERS EXAMINED THE SUBJECT DEVICE HANDPIECE, CONCLUDING THE HAND PIECE WIRING WAS INCORRECTLY ROUTED ADJACENT TO THE MOTOR RESULTING IN AN ELECTRICAL SHORT OF THE MOTOR. THE WIRING FAULT IS THE DETERMINED ROOT-CAUSE OF THE CUSTOMER'S COMPLAINT. THE HOSPITAL WAS PROVIDED A REPLACEMENT UNIT AS A CORRECTIVE MEASURE. THIS MEDICAL DEVICE REPORT IS BEING FILED SINCE THE REPORT OF SUBJECT DEVICE HANDPIECE PERFORMANCE ISSUES ARE SIMILAR TO ISSUES REPORTED IN EVENT REPORT 3004135191-2015-00026.

    Description of Event or Problem · 1

    A SURGEON IN ITALY REPORTED THAT WHILE ATTEMPTING TO USE A LUMENIS VERSACUT+ TISSUE MORCELLATOR, THE HAND PIECE PRESENTED, "PROBLEMS OF MORCELLATION", DURING A HOLEP PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426030 VERSACUT+ TISSUE MORCELLATOR SOFT TISSUE MORCELLATOR AND ACCESSORIES GCJ LUMENIS, LTD. VERSACUT+ TISSUE MORCELLATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other