BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT INSTRUMENT

    MDR report key: 3864252 · Received June 10, 2014

    Report

    Report Number
    2955842-2014-03563
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT THE PITCH CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THE PITCH CABLE WAS FOUND LOOSE AT THE DISTAL CLEVIS HUB. BOTH CABLE CRIMPS REMAINED IN THE CLEVIS AND FOUND FRAYED AT THE DISTAL CLEVIS HUB AREA. THE HOUSING WAS REMOVED AND THE PITCH CABLE WAS FOUND LOOSE AT THE CLAMPING PULLEY, BUT NO LOOSE CLAMPING PULLEY SCREW WAS FOUND. THE CLAMPING PULLEY WAS CORRODED/CONTAMINATED. RESIDUE WAS FOUND AT THE CABLE RAILS AREA ON THE CLAMPING PULLEY. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. THERE WAS AN INDENTATION AT THE INNER EDGE OF THE DISTAL PULLEY AND VISIBLE SCRATCHES ON THE SURFACE OF THE PULLEY. THE EVIDENCE WAS INCONCLUSIVE, BUT DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS EXHIBITING LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE MAIN TUBE. 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 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 CABLE DAMAGE AND/OR THE TUBE ABRASIONS, 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 WIRE WAS NOTED TO BE BROKEN PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT, NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337623 PROGRASP FORCEPS INSTRUMENT INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10131008 976

    Patients

    Seq Age Sex Outcome Treatment
    1