BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3081570 · Received April 29, 2013

    Report

    Report Number
    2955842-2013-01425
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND ONE GRIP CLOSE CABLE FRAYED AT THE FORCE AMP PULLEY. FRAYED STRANDS WERE OBSERVED TO BE STICKING OUT AT THE INSTRUMENT'S WRIST. THE OTHER CABLES OF THE INSTRUMENT'S WRIST DID NOT EXHIBIT ANY DAMAGE. ENGINEERING EVALUATION ALSO FOUND A DAMAGED PULLEY. THE FORCE AMP PULLEY WAS FOUND TO HAVE A SMALL GOUGE ON ONE EDGE. THE DAMAGED EDGE WAS ADJACENT TO WHERE CABLE FRAY INITIATED. ENGINEERING EVALUATION CONCLUDED THAT THE PULLEY DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE AND LIKELY CONTRIBUTED TO CABLE FRAYING. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. ON (B)(4) 2013, ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT NOTHING FELL INTO A PATIENT AND THERE WAS NO PATIENT HARM. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS OBSERVED DURING CENTRAL PROCESSING THAT THE PROGRASP FORCEPS INSTRUMENT HAD A BROKEN WIRE. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184584 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10120305 425

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES