BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL GRASPING RETRACTOR INSTRUMENT

    MDR report key: 4171442 · Received October 14, 2014

    Report

    Report Number
    2955842-2014-05478
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE PITCH CABLE IS BROKEN AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DOES NOT EXHIBIT ANY WEAR. THE BROKEN STRANDS STICK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. INTUITIVE SURGICAL, INC. (ISI) HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE AND DID NOT FIND ANY NON-CONFORMANCES THAT WERE RELATED TO THE REPORTED EVENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE BROKEN PITCH CABLE FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI COLON RESECTION PROCEDURE, THE CABLE ON THE SMALL GRASPING RETRACTOR INSTRUMENT BROKE. THERE WAS NO ALLEGATION THAT ANY PIECE(S) FROM THE INSTRUMENT FELL INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650544 SMALL GRASPING RETRACTOR INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420318-02 M10130121 277

    Patients

    Seq Age Sex Outcome Treatment
    1