BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMMENT

    MDR report key: 2891921 · Received December 31, 2012

    Report

    Report Number
    2955842-2012-01489
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS RETURNED WITH THE CONDUCTOR CAP DETACHED FROM THE DISTAL END. THE CAP IS INTACT, BUT HAS A CRACKED SECTION AROUND THE OUTER EDGE. THE CONDUCTOR WIRE IS EXPOSED AT THE DISTAL END AS A RESULT OF CAP DISLODGMENT. THE YAW PULLEY BOSS FEATURE THAT MATES WITH CAP IS BROKEN OFF. ENGINEERING EVALUATION ALSO FOUND THAT THE CLEVIS HAS AN AXIALLY ALIGNED CRACK HALFWAY BETWEEN THE EARS. THE LOCATION OF THE CRACK IS ON THE SAME SIDE AS THE CONDUCTOR WIRE/CAP, WHICH INDICATES OVERLOADING AT THE TIP OCCURRED WITH WHEN THE WRIST WAS PITCHED. ENGINEERING CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE FOUND. 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 ROUND PLASTIC PIECE FROM THE JOINT ON THE PERMANENT CAUTERY HOOK INSTRUMENT CAME OUT. LATE SUBMISSION OF THIS MEDWATCH REPORT IS DUE TO A REPORTING OVERSIGHT BY THE RESPONSIBLE COMPLAINT HANDLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK INSTRUMMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-04 M10100210 944

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURGICAL SYSTEM, ACCESSORIES AND ESU.