BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE FENESTRATED GRASPER INSTRUMENT

    MDR report key: 4781205 · Received May 19, 2015

    Report

    Report Number
    2955842-2015-00759
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    March 24, 2015
    Report Date
    May 18, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATION. FAILURE ANALYSIS INVESTIGATION FOUND THAT THE INSTRUMENT PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINED THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE WAS CONDUCTED AND DID NOT FIND ANY NON-CONFORMANCES THAT WOULD AFFECT ANY MATERIAL OF THE FINAL PRODUCT AND/OR THE QUALITY OR PERFORMANCE OF THE INSTRUMENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE BROKEN PITCH CABLE FOUND DURING FAILURE ANALYSIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, A WIRE WAS FOUND TO BE BROKEN ON THE DOUBLE FENESTRATED GRASPER INSTRUMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THERE WERE NO REPORTS OF ANY FRAGMENT(S) FALLING INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325051 DOUBLE FENESTRATED GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420189-09 M10140214 015

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR