BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    MDR report key: 3070906 · Received April 22, 2013

    Report

    Report Number
    2955842-2013-01340
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    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, ENGINEERING EVALUATION FOUND THAT THE INSTRUMENT HAD CABLES BROKEN AT THE SNAKE WRIST. THE FIRST WRIST DISC AT THE DISTAL END WAS FOUND DISLOCATED. THE INSTRUMENT BLADE REMAINED INSIDE THE GARAGE POSITION. THE INSTRUMENT CAUTERY CABLE WAS CUT PRIOR TO RETURNING. THE SYSTEM LOGS WERE SEARCHED AND IT WAS FOUND THAT MULTIPLE INCOMPLETE CUTS WERE FOUND IN THE MSC (MASTERY SUPERVISOR CONTROLLER) LOGS FOLLOWED WITH THREE SYSTEM_ERR_TOOL_INVALID_REASON MESSAGES AND NORMAL USAGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI COLON RESECTION PROCEDURE THE ENDOWRIST ONE VESSEL SEALER INSTRUMENT WAS NOTED TO HAVE WIRES EXPOSED AT THE SHAFT. NO MISSING OR FALLEN PIECES WERE REPORTED. 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
    172161 ENDOWRIST ONE VESSEL SEALER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 S10130102 208

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES