BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST ONE VESSEL SEALER INSTRUMENT

    MDR report key: 3103429 · Received May 9, 2013

    Report

    Report Number
    2955842-2013-01575
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 5, 2013
    Report Date
    April 22, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K110639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RECEIVED AND EVALUATED. ENGINEERING PERFORMED VISUAL INSPECTION OF THE INSTRUMENT AND CONFIRMED AN EXPOSED BLADE BETWEEN THE INSTRUMENT'S GRIPS. THERE WAS ALSO SOME BIO DEBRIS WITHIN THE BLADE TRACKS, POSSIBLY AFFECTING THE BLADE TRAVEL. ADDITIONAL DAMAGE FOUND NOT REPORTED BY THE CUSTOMER WERE BROKEN CABLES. TWO DRIVE CABLES WERE STICKING OUT AT THE DISTAL END OF THE SNAKE WRIST. WRIST MOTION WILL NOT BE INTUITIVE DUE TO THE CABLE BREAKAGE. SNAKE WRIST DISCS DID NOT EXHIBIT ANY OBVIOUS DAMAGE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    DURING A DA VINCI SI SURGICAL PROCEDURE, THE USER FACILITY REPORTEDLY IDENTIFIED A BLADE ON THE VESSEL SEALER INSTRUMENT WAS NOT RETURNING TO THE HOUSING. NOTHING REPORTEDLY FELL INTO A 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
    203848 ENDOWRIST ONE VESSEL SEALER INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 410322-04 S10121130 696

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES, ESU