BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3881306 · Received June 18, 2014

    Report

    Report Number
    2955842-2014-03726
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT ONE GRIP WAS BENT, CAUSING SIDE-TO-SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A .288 OFFSET AT THE TIPS, INDICATING OVERLOADING AT THE TIP. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THERE WAS AN INDENTATION AT THE EDGE OF THE DISTAL PULLEY. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS 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 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 ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE TUBE ABRASIONS, 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 THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT PRONGS WERE NOT COMING TOGETHER A DA VINCI LAPAROSCOPIC PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT, NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357008 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-07 N10140326 416

    Patients

    Seq Age Sex Outcome Treatment
    1