BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 4223558 · Received November 4, 2014

    Report

    Report Number
    2955842-2014-05588
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    September 12, 2014
    Report Date
    October 1, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND A BROKEN PITCH CABLE AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. THE BROKEN STRANDS STUCK OUT AT THE INSTRUMENTS' WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE BROKEN PITCH CABLE FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT RESPONDING AFTER RESEATING. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707434 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-07 N10140619 701

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR