BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 3671348 · Received March 10, 2014

    Report

    Report Number
    2955842-2014-01431
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    January 10, 2014
    Report Date
    February 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERMANENT CAUTERY HOOK INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND INSTRUMENT DISTAL CLEVIS WAS BROKEN AT THE MAIN TUBE INTERFACE. THE CLEVIS EXHIBITS AREA WHERE MATERIAL WAS MISSING, WHICH MEASURED ROUGHLY .323, OTHER AREA .055 AND .029. THE CABLES WERE STILL ATTACHED. IT WAS CONCLUDED THAT THE BROKEN CLEVIS MAY HAVE BEEN DUE TO MISHANDLING. FAILURE ANALYSIS INVESTIGATION ALSO FOUND INSTRUMENT MAIN TUBE WAS BROKEN AT THE DISTAL CLEVIS HUB INTERFACE. THE MAIN TUBE EXHIBITS DAMAGE AND MATERIAL MISSING MEASURING ROUGHLY 0.77 X .202 AND .108 X .173. ALSO, THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .240 - .295 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. A LARGE AREA EXHIBITS LIGHT MATERIAL SCRATCHED, WHICH MAY HAVE BEEN CAUSED BY ATTEMPTING TO REMOVE THE INSTRUMENT FROM THE CANNULA. IN ADDITION, THE DISTAL PULLEY EXHIBITED MECHANICAL INDENTATIONS ON THE EDGES AND A SCRATCH ACROSS THE SURFACE OF THE PULLEY. NO OTHER DAMAGE WAS FOUND. IT WAS CONCLUDED THAT THE MAIN TUBE BREAKAGE AND THE MECHANICAL INDENTATIONS ON THE DISTAL PULLEY MAY HAVE BEEN DUE TO MISHANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI THYMECTOMY PROCEDURE, ABOUT 1 HOUR INTO THE SURGERY, THE COAGULATING HOOK (PERMANENT CAUTERY HOOK INSTRUMENT) GOT STUCK AT THE TROCAR. THE INTERVENTION WAS FINISHED WITH A NEW HOOK, SURGERY TOOK 45 MINUTES LONGER. INTUITIVE SURGICAL INC. CONTACTED THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING REPORTED COMPLAINT. CUSTOMER INDICATED THAT THE INSTRUMENT BROKE AND IT WAS NOT POSSIBLE TO GET IT OUT OF THE TROCAR (CANNULA) SO THE INSTRUMENT + TROCAR WERE REMOVED FROM THE INSTRUMENT ARM OF THE ROBOT. NO FRAGMENT FELL INTO THE PATIENT AND THE INSTRUMENT WILL BE RETURNED TO ISI FOR ANALYSIS. THE INSTRUMENT WAS CHANGED AND THE PROCEDURE WAS PERFORMED AS PLANNED, WITHOUT ANY CONSEQUENCE FOR THE PATIENT. NO CLINICAL CONSEQUENCE FOR THE PATIENT, NO POST-OPERATIVE CONSEQUENCE OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142534 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-04 S10090818 674

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR