BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3934765 · Received July 15, 2014

    Report

    Report Number
    2955842-2014-04262
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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 THE DISTAL IDLER. NO DAMAGE WAS FOUND ON THE CLEVIS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING: THE INSTRUMENT'S DISTAL PULLEY HAD MECHANICAL INDENTATIONS AND BURRS. THERE WAS AN INDENTATION AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. FAILURE ANALYSIS CONCLUDED THAT THE MECHANICAL INDENTATION AND BURR DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS AND ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS AND ABRASIONS 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 PITCH 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 A BROKEN WIRE WAS OBSERVED ON THE TIP OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. 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
    414405 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 N10140131 338

    Patients

    Seq Age Sex Outcome Treatment
    1