BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 2872030 · Received December 11, 2012

    Report

    Report Number
    2955842-2012-01238
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS RETURNED WITH ONE GRIP BROKEN OFF. THE GRIP FRACTURED AT THE CROSS SECTION OF THE CABLE CRIMP, AT THE JUNCTION BETWEEN THE GRIP HUB AND GRIP ARM. THE LOCATION OF THE FRACTURE IS WHERE THE GRIP CROSS SECTIONAL AREA IS AT A MINIMUM. THE OUTER SURFACE OF THE BROKEN GRIP EXHIBITS SOME SCRATCH MARKS. NO OTHER DAMAGE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SACROCOLPOPEXY PROCEDURE, A FRAGMENT FROM THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT BROKE OFF AND FELL IN THE PT. THE FRAGMENT WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PT HARM ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGASUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT, NAY NAY INTUITIVE SURGICAL, INC. 420309-01 M10101111587

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR ACCESSORIES| DA VINCI SI SURGICAL SYSTEM