BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 2842728 · Received November 21, 2012

    Report

    Report Number
    2955842-2012-01025
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 22, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF BROKEN CABLE IS CONFIRMED. THE PITCH DOWN/UP CABLE IS BROKEN AT THE DISTAL CLEVIS HUB. CABLE SEGMENT THAT CONTAINS THE CRIMP IS STILL INSTALLED IN THE CLEVIS. CLEVIS DOES NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT WRIST ARE NOT DAMAGED. ADDITIONAL OBSERVATION NOT REPORTED BY SITE IS TUBE DAMAGE. DISTAL END OF MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SCRATCHES ARE .110 - .205 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE MAY HAVE BEEN CAUSED BY MISHANDLING/MISUSE. NO OTHER DAMAGE FOUND. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SALPINGECTOMY PROCEDURE, THE SURGICAL STAFF REPORTED SEEING A BROKEN CABLE ON THE PROGRASP FORCEPS INSTRUMENT. NOTHING WAS REPORTED HAVING FALLEN INTO THE PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10120529 652

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES