BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 4201237 · Received October 27, 2014

    Report

    Report Number
    2955842-2014-05541
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 24, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, 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 PRIOR STARTING A DA VINCI SURGICAL PROCEDURE, IT WAS NOTED THAT THE CABLE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS BROKEN. THERE WAS NO REPORT THAT ANY PIECE(S) FROM THE INSTRUMENT FELL INTO A PATIENT AND THERE WAS NO ALLEGATION OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY INVOLVING THE REPORTED INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681938 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-07 N10140606 439

    Patients

    Seq Age Sex Outcome Treatment
    1