BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACUT TISSUE MORCELLATOR

    MDR report key: 7850301 · Received September 6, 2018

    Report

    Report Number
    3004135191-2018-00118
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    August 21, 2018
    Report Date
    September 6, 2018
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEI
    PMA / PMN Number
    K050639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS CONTACTED THE FOREIGN USER FACILITY THROUGH ITS FOREIGN SUBSIDIARY TO INVESTIGATE THE REPORTED EVENT, AN INCIDENT REPORT HAD BEEN PROVIDED BY THE FACILITY. SINCE THIS MALFUNCTION LED TO A CANCELLED PROCEDURE, LUMENIS IS REPORTING THIS EVENT AS AN ADVERSE EVENT IN ADDITION TO THE MALFUNCTION. LUMENIS BELIEVES THAT SUBJECTING A PATIENT TO ANOTHER ROUND OF ANESTHESIA CARRIES INHERENT RISKS, THUS LUMENIS IS REPORTING THIS MALFUNCTION AS AN ADVERSE EVENT AS WELL. LUMENIS HAS INITIATED CAPA #: (B)(4) TO FURTHER INVESTIGATE INTERMITTENT VERSACUT HANDPIECE OPERATION, AND TO DETERMINE IF CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A FOREIGN USER FACILITY REPORTED THAT DURING A HOLEP PROCEDURE IN WHICH A LUMENIS VERSACUT MORCELLATOR WAS BEING UTILIZED, "THE MOVEMENT OF THE HANDPIECE WAS NOT SMOOTH, AND THE HANDPIECE FINALLY STOPPED". THE DOCTOR HAD STOPPED THE PROCEDURE AND AFTER RECEIVING A NEW HANDPIECE THREE (3) DAYS LATER, THE DOCTOR SUCCESSFULLY COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692285 VERSACUT TISSUE MORCELLATOR SOFT TISSUE MORCELLATOR AND ACCESSORIES GEI LUMENIS LTD. VERSACUT MORCELLATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other