BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 2851902 · Received November 29, 2012

    Report

    Report Number
    2955842-2012-01131
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. CUSTOMER INITIALLY REPORTED BROKEN CABLE. HOWEVER FOR CLARIFICATION, THE NONCONFORMANCE WAS A FRAYED PITCH CABLE. BASED ON THIS, THE COMPLAINT WAS CONFIRMED. FRAYED PITCH CABLE WAS FOUND AT DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. FRAYED SEGMENTS ARE IN VARIOUS LENGTHS. ADDITIONAL OBSERVATION NOT REPORTED BY THE CUSTOMER WAS INSULATION DAMAGE OF THE MAIN TUBE. MATERIAL HAS BEEN REMOVED AND MISSING. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE LIKELY DUE TO MISHANDLING. 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 THE PROGRASP FORCEPS INSTRUMENT HAD A BROKEN CABLE. 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 M10110425 197

    Patients

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