BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 2925903 · Received January 22, 2013

    Report

    Report Number
    2955842-2013-00264
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 A FRAYED PITCH CABLE AT DISTAL CLEVIS HUB. NO EXCESSIVE DAMAGE WAS FOUND AT THE CLEVIS. THE FRAYED SEGMENT IS APPROXIMATELY 0.03 IN LENGTH. 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 REPROCESSING OF THE PK DISSECTING FORCEPS INSTRUMENT IT WAS NOTED THAT THE WIRE ON THE INSTRUMENT WAS BROKEN. THERE WERE NO MISSING OR FALLEN PIECES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30323 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120831 353

    Patients

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