BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2842738 · Received November 21, 2012

    Report

    Report Number
    2955842-2012-01026
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 22, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ADDITIONAL OBSERVATION NOT REPORTED BY SITE IS A BROKEN CABLE. ONE GRIP CLOSE CABLE IS BROKEN AT THE DISTAL IDLERS. IDLER PULLEY SPINS FREELY AND DOES NOT EXHIBIT DAMAGE. CABLE SEGMENT STICKS OUT AT WRIST. OTHER CABLES AT WRIST ARE NOT DAMAGED. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SACROCOLPOPEXY PROCEDURE, THE SURGICAL STAFF REPORTED THEY WERE WORKING ON THE SEWING THE Y MESH TO THE SACRUM. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(4) 2012 FAILURE ANALYSIS RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT AND DETECTED A CABLE BREAK ON THE INSTRUMENT. THE COMPLAINT WAS EVALUATED AND MADE REPORTABLE BASED ON THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10120302 014

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES