BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3760437 · Received April 21, 2014

    Report

    Report Number
    2955842-2014-02386
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 25, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND ONE GRIP WAS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A .082 OFFSET AT THE TIPS, INDICATING OVERLOADING AT THE TIP. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE MAY HAVE BEEN DUE TO MISHANDLING. FAILURE ANALYSIS INVESTIGATION ALSO FOUND FOLLOWING DAMAGES, WHICH WERE NOT REPORTED: INSTRUMENT'S PITCH CABLE WAS FOUND TO BE FRAYED AT THE DISTAL CLEVIS HUB. THERE WAS NO DAMAGE AT THE CLEVIS. THERE WERE INDENTATIONS AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. FAILURE ANALYSIS CONCLUDED THAT THE INDENTATIONS WERE LIKELY DUE TO MISHANDLING. ALSO, THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE HAD VARIOUS SCRATCH MARKS SHOWING 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 ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE FRAYED PITCH CABLE AND THE MAIN TUBE MATERIAL REMOVAL FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI GYNECOLOGY PROCEDURE, THE TIPS OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WERE MISALIGNED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240687 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 N10131218 526

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR