BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 4242806 · Received November 11, 2014

    Report

    Report Number
    2955842-2014-05645
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 14, 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 INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THAT THE INSTRUMENT PITCH CABLE WAS BROKEN AT THE PROXIMAL CLEVIS HUB. THE BROKEN STRANDS STUCK OUT AT THE INSTRUMENT WRIST. NO OTHER DAMAGE OR WEAR MARKS WERE OBSERVED ON THE CLEVIS. THE OTHER CABLES AT THE WRIST WERE INTACT AND UNDAMAGED. INTUITIVE SURGICAL, INC. (ISI) HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE AND DID NOT FIND ANY NON-CONFORMANCES THAT WOULD AFFECT ANY MATERIAL OF THE FINAL PRODUCT AND/OR THE QUALITY OR PERFORMANCE OF THE INSTRUMENT USED DURING THIS REPORTED EVENT. THE REPORTED COMPLAINT THAT THE INSTRUMENT WAS SPASTIC WITH STRANGE MOVEMENT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT. RECURRENCE OF THE ALLEGED FAILURE MODE IS NOT EXPECTED TO LIKELY CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT. HOWEVER, THE BROKEN PITCH CABLE FOUND DURING FAILURE ANALYSIS INVESTIGATION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT BEHAVED LIKE A SPASTIC ARM, AND STRANGE MOVEMENT WAS REPORTED. THERE WAS NO REPORT OF FRAGMENTS FALLING 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
    725634 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-09 N10140407 015

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR