BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3833022 · Received May 27, 2014

    Report

    Report Number
    2955842-2014-03231
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 CLAMPING PULLEY AT THE BACKEND OF THE INSTRUMENT, INSIDE THE HOUSING. THE PULLEY DID NOT EXHIBIT ANY WEAR. 48, 80 - FAILURE ANALYSIS ALSO FOUND THE FOLLOWING DAMAGES, WHICH WERE NOT REPORTED: ONE GRIP HAD INDENTATIONS AT THE MIDPOINT. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. THE TOP PART OF THE INSTRUMENT BIPOLAR PIN WAS BENT AT THE BACKEND OF THE HOUSING. THE BIPOLAR INSERT WAS STILL INTACT. THE ELECTRICAL CONTINUITY TEST WAS PERFORMED AND PASSED. FAILURE ANALYSIS CONCLUDED THAT THE BENT PIN WAS LIKELY DUE TO MISHANDLING. ONE OF THE INSTRUMENT GRIPS WAS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A .015 OFFSET AT THE TIPS. THE BENT GRIP DID NOT EXHIBIT A SEPARATION OF THE YAW PULLEY COVER AT THE GLUE JOINT, LIKELY CAUSE OF BENDING REMAINS OVERLOADING AT THE TIP. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, THE CABLE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311353 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10130509 526

    Patients

    Seq Age Sex Outcome Treatment
    1