BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACUT TISSUE MORCELLATOR

    MDR report key: 7047933 · Received November 21, 2017

    Report

    Report Number
    3004135191-2017-00220
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Report Date
    November 21, 2017
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEI
    PMA / PMN Number
    K050639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS CONTACTED THE FOREIGN USER FACILITY THROUGH ITS FOREIGN SUBSIDIARY TO INVESTIGATE THE REPORTED EVENT, OTHER THAN THE INITIAL REPORT NO ADDITIONAL INFORMATION HAD BEEN PROVIDED. ALTHOUGH NO INJURY WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT, LUMENIS IS AWARE THAT THE SAME MALFUNCTION WAS ALLEGED TO HAVE CAUSED OR CONTINUED TO A 'SERIOUS INJURY' (CANCELLED PROCEDURE OF AN ANESTHESIZED PATIENT : MDR# 3004135191-2017-00186). LUMENIS IS REPORTING THIS EVENT AS IT REPRESENTS A REPORTABLE MALFUNCTION. LUMENIS INITIATED CAPA # (B)(4) TO CONTINUE ITS INVESTIGATION OF THIS AND SIMILAR REPORTED EVENTS, AND TO DETERMINE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    A FOREIGN USER FACILITY REPORTED THAT WHILE PERFORMING A HOLEP PROCEDURE, THE DOCTOR EXPERIENCED INTERMITTENT OPERATION OF THEIR VERSACUT TISSUE MORCELLATOR, BUT ONCE THE DOCTOR CHANGED THE ANGLE OF THE HANDPIECE TO OPERATE, THE PERFORMANCE WAS RESTORED AND THE SURGERY WAS FINISHED SUCCESSFULLY. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829914 VERSACUT TISSUE MORCELLATOR SOFT TISSUE MORCELLATOR GEI LUMENIS LTD. VERSACUT MORCELLATOR

    Patients

    Seq Age Sex Outcome Treatment
    1