BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 4102714 · Received September 19, 2014

    Report

    Report Number
    2955842-2014-05380
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE PITCH UP CABLE BROKEN AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT WRIST ARE NOT DAMAGED. ISI HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE AND DID NOT FIND ANY NON-CONFORMANCES THAT WERE RELATED TO THIS 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 SURGICAL PROCEDURE, A BROKEN CABLE WAS IDENTIFIED ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583575 FENESTRATED BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-07 N10140529 878

    Patients

    Seq Age Sex Outcome Treatment
    1