BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3884656 · Received June 19, 2014

    Report

    Report Number
    2955842-2014-03783
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT BOTH PITCH CABLES AT THE DISTAL CLEVIS HUB WERE FRAYED. THE FRAYED SEGMENTS WERE IN VARIOUS LENGTHS. FAILURE ANALYSIS ALSO OBSERVED BOTH INSTRUMENT PITCH CABLES WERE LOOSE. INTUITIVE MOTION WAS NOT BEING EXPERIENCED. THE HOUSING WAS REMOVED AND CORROSION WAS FOUND RESIDING AROUND THE CLAMPING PULLEY AND BEARINGS WHERE THE PITCH CABLES ROUTED. THE PITCH CABLES AT THE CLAMPING PULLEY WAS FOUND LOOSE, BUT NO LOOSE CLAMPING PULLEY SCREW WAS FOUND. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGES WERE DUE TO IMPROPER CLEANING. NO OTHER DAMAGE WAS FOUND. THE REPROCESSING INSTRUCTIONS UNDER CLEANING, DISINFECTION, AND STERILIZATION GENERAL INFORMATION SECTION SPECIFICALLY STATES: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE DAMAGED CABLE, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRASP FORCEPS INSTRUMENT CABLE WAS NOTED TO BE FRAYED DURING A DA VINCI SURGICAL PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360521 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-11 N10140422 358

    Patients

    Seq Age Sex Outcome Treatment
    1