BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACUT TISSUE MORCELLATOR

    MDR report key: 7044736 · Received November 20, 2017

    Report

    Report Number
    3004135191-2017-00217
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 20, 2017
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEI
    PMA / PMN Number
    K050639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS CONTACTED THE FOREIGN USER FACILITY THROUGH ITS FOREIGN SUBSIDIARY TO INVESTIGATE THE REPORTED EVENT, HOWEVER NO ADDITIONAL INFORMATION HAD BEEN PROVIDED OTHER THAN THE INITIAL REPORT. 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 ANESTHETIZED 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 OPERATOR EXPERIENCED INCONSISTENT TISSUE MORCELLATION WHILE UTILIZING THEIR VERSACUT MORCELLATOR. NO REPORT OF SERIOUS INJURY NOR REPORT OF MEDICAL INTERVENTION TO PRECLUDE SERIOUS INJURY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823512 VERSACUT TISSUE MORCELLATOR SOFT TISSUE MORCELLATOR GEI LUMENIS LTD. VERSACUT MORCELLATOR

    Patients

    Seq Age Sex Outcome Treatment
    1