BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 2970543 · Received February 20, 2013

    Report

    Report Number
    2955842-2013-00562
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 23, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 PITCH CABLE FRAYED AND LOOSE AT THE DISTAL CLEVIS HUB, AND THE CABLES WERE FOUND DERAILED AT THE CLAMPING PULLEY. ENGINEERING EVALUATION ALSO FOUND THAT THE CABLES AND IDLER BLOCK PULLEY AT THE BACK END OF THE HOUSING EXHIBITED CHEMICAL ATTACK AND HAD RUST. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE TIP OF THE INSTRUMENT BENT. 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
    74333 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420207-06 M10120403 245

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG SYSTEM AND ACCESSORIES.