BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3230597 · Received July 16, 2013

    Report

    Report Number
    2955842-2013-02577
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 19, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE ONE GRIP WAS BENT, CAUSING SIDE-TO-SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A .030 OFFSET AT THE TIPS. THE BENT GRIP HAD SEPARATION OF THE YAW PULLEY AND THE PULLEY COVER AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. ENGINEERING ALSO FOUND TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .080 - .140 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY CAUSED BY MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY WITH LYMPH NODE DISSECTION PROCEDURE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIPS WERE ALLEGEDLY NOT APPROXIMATING. NO MISSING OR FALLEN PIECES WERE REPORTED. 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
    328062 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10121126 206

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES