BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 3870325 · Received June 12, 2014

    Report

    Report Number
    2955842-2014-03613
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    April 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THAT INTUITIVE MOTION WAS NOT BEING EXPERIENCED BECAUSE THE PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERMANENT CAUTERY HOOK INSTRUMENT STOPPED RESPONDING DURING A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO PROCEDURE. IT WAS NOTED THAT THE WIRE WAS EXPOSED AND A BACKUP INSTRUMENT WAS USED TO COMPLETE THE PLANNED PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347206 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-06 M10130919 887

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR