BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 3206023 · Received July 3, 2013

    Report

    Report Number
    2955842-2013-02433
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE CUSTOMER REPORT COMPLAINT, AS THE INSTRUMENT WAS RETURNED WITH THE SMALL DISTAL CLEVIS PLASTIC PIN BROKEN AND MISSING FROM THE DISTAL CLEVIS; HOWEVER, THE BROKEN PIECE WAS RETURNED WITH THE INSTRUMENT. NO OTHER DAMAGE WAS FOUND. ON (B)(4) 2013 INTUITIVE SURGICAL, INC. CONTACTED THE DA VINCI COORDINATOR AT THE SITE. THE DA VINCI COORDINATOR INDICATED THAT THE BROKEN INSTRUMENT PIECE WAS REMOVED FROM THE PATIENT THROUGH AN ASSISTANT PORT USING A TRADITIONAL LAPAROSCOPIC INSTRUMENT. THIS COMPLAINT IS BEING REPORTED DUE TO A FRAGMENT FROM THE REPORTED INSTRUMENT FELL INTO THE PATIENT DURING A DA VINCI SURGICAL PROCEDURE. PER THE INFORMATION PROVIDED BY THE SITE, THE BROKEN INSTRUMENT PIECE WAS RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S CHOLECYSTECTOMY PROCEDURE, THE PLASTIC SCREW AT THE DISTAL END OF THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT FELL INTO THE PATIENT. THE INSTRUMENT COMPONENT WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305331 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-06 M10130121 905

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR DA VINCI S SURG. SYS, INSTRUMENTS, ACCESS & ESU.