BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTATION MORCELLATOR BLADE

    MDR report key: 5057739 · Received September 4, 2015

    Report

    Report Number
    1418479-2015-00028
    Event Type
    Injury
    Date Received
    September 4, 2015
    Report Date
    August 12, 2015
    Manufacturer
    RICHARD WOLF GERMANY (GMBH)
    Product Code
    GEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE DOCTOR HAS HAVING PROBLEMS WITH THE PIRANHA SYSTEM, A LASER ENUCLEATION SYSTEM. DOCTOR TESTED A NUMBER OF EQUIPMENT SET UPS AND CONNECTIONS BEFORE GETTING THE SYSTEM TO WORKING PROPERLY AND COMPLETED THE PROCEDURE AS SCHEDULED. ONCE SYSTEM WAS WORKING DOCTOR FOUND THE BLADDER WAS NICKED. THE SYSTEM CONSISTS OF THE FOLLOWING DEVICES: PUMP KIT (INCLUDES: SUCTION PUMP, POWER CORD, FOOT PEDAL, FILTER, VACUUM TUBE, BOTTLE BRACKET, FILTER & CONNECTING CABLE), ENDOSCOPE, MORCELLETOR HANDPIECE, POWER CONTROL UNIT, MORCELLATOR BLADE. THE MORCELLATOR BLADE IS THE SUSPECT DEVICE WHICH NICKED THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588837 ROTATION MORCELLATOR BLADE ROTATING BLADE GEY RICHARD WOLF GERMANY (GMBH) 49700113

    Patients

    Seq Age Sex Outcome Treatment
    1 Other