BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS IBSTRUMENT

    MDR report key: 3912099 · Received July 3, 2014

    Report

    Report Number
    2955842-2014-04071
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S PITCH CABLE WAS FRAYED. THE INSTRUMENT WAS FOUND WITH A FRAYED PITCH CABLE AT DISTAL IDLER. NO DAMAGE WAS FOUND ON THE PULLEY AND CLEVIS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING: THE INSTRUMENT'S CONDUCTOR WIRE HAD DAMAGED INSULATION. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGED INSULATION WAS LIKELY DUE TO MISHANDLING/MISUSE. THERE WERE SCRATCH MARKS ON THE MAIN TUBE. THE DISTAL END OF THE MAIN TUBE HAD SCRATCH MARKS 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. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE FRAYED CABLE AND DAMAGE TO THE MAIN TUBE FOUND DURING FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, A FRAYED CABLE WAS OBSERVED ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390126 FENESTRATED BIPOLAR FORCEPS IBSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10131108 964

    Patients

    Seq Age Sex Outcome Treatment
    1