BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORCELLATOR

    MDR report key: 3073460 · Received April 23, 2013

    Report

    Report Number
    3003604053-2013-00008
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ANDOVER MANUFACTURING SITE
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED RECIPROCATIN MORCELLATOR INDICATED THAT THERE WAS NO DAMAGE TO THE DEVICE ADAPTER BODY OR SLUFF CHAMBER. UPON MANIPULATING THE DEVICES, IT WAS NOTED THAT THE SLUFF CHAMBER WOULD TURN, AND THE INNER BLADE ASSEMBLY RECIPROCATED AS INTENDED. WINDOW LOCK COULD BE ACHIEVED MANUALLY AND USING A TRUCLEAR HANDPIECE. THE DIMENSIONAL INSPECTION INDICATED THAT THE OUTER DIAMETER IS UNDERSIZED WHEN COMPARED TO THE COMPONENT SPECIFICATION, ALLOWING FOR INCREASED PASSAGE OF FLUID. A CORRECTIVE ACTION HAS BEEN OPENED IN RESPONSE TO THIS ISSUE. ROOT CAUSE ANALYSIS AND THE RESULTING ACTION PLAN ARE DOCUMENTED IN CAPA FILE #(B)(4).

    Description of Event or Problem · 1

    FIVE MINUTES INTO THE CASE STARTED TO GO THROUGH LARGE AMOUNT OF FLUID; NO VISUALIZATION. DOCTOR TOOK BLADE OUT TO RE-WINDOW LOCK AND IT WORKED FOR ABOUT 60 SECONDS AND THE SAME THING HAPPENED AGAIN, NO VISUALIZATION. DEFICIT WAS 1800 TOTAL FLUID. THE REASON FOR THE DEFICIT WAS THERE WAS FLUID ALL OVER THE FLOOR. THE PROCEDURE WAS NOT COMPLETED THERE IS NO INFORMATION AS TO WHAT THE SURGEON'S NEXT STEP WAS. SMITH & NEPHEW REQUESTED THAT SHE CALL THE PHYSICIAN TO CHECK ON THE PATIENT STATUS. THIS PROCEDURE WAS PERFORMED IN THE OFFICE NOT IN THE HOSPITAL. TWO ATTEMPTS HAVE BEEN MADE BY THE SALES REP. TO OBTAIN PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173790 MORCELLATOR 4.0 RECIPROCATING MORCELLATOR HIH ANDOVER MANUFACTURING SITE 72203012 A18915

    Patients

    Seq Age Sex Outcome Treatment
    1