BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPSINSTRUMENT

    MDR report key: 2933688 · Received January 29, 2013

    Report

    Report Number
    2955842-2013-00310
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 2, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE ALLEGED COMPLAINT OF A FRAYED INSTRUMENT CABLE WAS CONFIRMED. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND TO HAVE A FRAYED AND BROKEN CABLE AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP STILL REMAINED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT EXCESSIVE DAMAGE. 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF ALLEGEDLY FOUND A FRAYED CABLE ON THE PK DISSECTING FORCEPS INSTRUMENT. THERE WERE NO MISSING OR FALLEN PIECES 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
    39321 PK DISSECTING FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120912 585

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES