BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 4017582 · Received August 18, 2014

    Report

    Report Number
    2955842-2014-05010
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND ONE GRIP WAS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A .035 OFFSET AT THE TIPS. THE BENT GRIP DID NOT EXHIBIT SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, HOWEVER LIKELY CAUSE OF BENDING REMAINS OVERLOADING AT THE TIP. FAILURE ANALYSIS CONCLUDED THAT THE BENT GRIP DAMAGE WAS LIKELY DUE TO MISHANDLING. FAILURE ANALYSIS ALSO OBSERVED THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .032 - .125 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. 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 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 PRIOR TO STARTING A DA VINCI GASTRIC SLEEVE RESECTION PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS PULLED OUT OF TRAY AND NOTICED THE GRASPERS WERE OFF CENTER. THE INSTRUMENT WAS TAKEN OFF FIELD AND ANOTHER WAS OPENED. NO FRAGMENTS FELL INTO THE PATIENT. 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
    495362 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-07 M10140318 026

    Patients

    Seq Age Sex Outcome Treatment
    1