BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3894902 · Received June 25, 2014

    Report

    Report Number
    2955842-2014-03896
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND ONE GRIP BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS PREVENTING FROM CLOSING PROPERLY. THERE WAS A .111 OFFSET AT THE TIPS, INDICATING OVERLOADING AT THE TIP. THE ELECTRICAL CONTINUITY TEST WAS PERFORMED AND PASSED. FAILURE ANALYSIS CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING. FAILURE ANALYSIS INVESTIGATION ALSO FOUND A FRAYED PITCH CABLE AT THE DISTAL IDLER. THERE WAS NO DAMAGE ON THE CLEVIS. THERE WERE INDENTATIONS AT THE EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. NO OTHER DAMAGE WAS FOUND. FAILURE ANALYSIS CONCLUDED THAT THE INDENTATIONS WERE LIKELY DUE TO MISHANDLING. 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 CABLE 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 HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIPS WERE NOT CLOSING. ANOTHER INSTRUMENT WAS USED TO COMPLETE PROCEDURE. THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369803 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 N10140206 558

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR