BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 3791445 · Received May 5, 2014

    Report

    Report Number
    2955842-2014-02795
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 9, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE TIPS OF THE INSTRUMENTS GRIPS WERE BENT. ONE GRIP WAS BENT, CAUSING A SIDE TO SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A .082 OFFSET AT THE TIP INDICATING OVERLOADING. ELECTRICAL CONTINUITY TESTING WAS PERFORMED AND PASSED. FAILURE ANALYSIS CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING / MISUSE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING DAMAGES TO THE INSTRUMENT: THE GRIP CABLE FRAYED AT THE DISTAL IDLER PULLEY. FRAYED STRANDS STUCK OUT AT THE INSTRUMENT'S WRIST. THE PITCH CABLE FRAYED AT THE DISTAL IDLER. NO DAMAGE WAS FOUND ON THE CLEVIS. AN INDENTATION AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HIATAL HERNIA PROCEDURE, THE TEETH WERE NOT ALIGNED ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. NOTHING REPORTEDLY FELL 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
    266361 FENESTRATED BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10130808 736

    Patients

    Seq Age Sex Outcome Treatment
    1