BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3173408 · Received June 17, 2013

    Report

    Report Number
    2955842-2013-02190
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 28, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT THAT THE INSTRUMENT WOULD NOT CAUTERIZE. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM FOR A CAUTERY TEST AND THE INSTRUMENT SUCCESSFULLY PASSED THE TEST BY WITNESSING FUMES FROM WET MATERIAL AFTER THE TEST WAS INITIATED. ENGINEERING FOUND DEEP SCRATCHES 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 VARIED IN LENGTH MEASURING APPROXIMATELY FROM .0465 TO .5395 IN LENGTH. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE DAMAGE TO THE INSTRUMENT'S MAIN TUBE, WHICH WAS FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI CYSTECTOMY PROCEDURE THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WOULD NOT CAUTERIZE. 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
    274314 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10111220 529

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES