BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3935729 · Received July 15, 2014

    Report

    Report Number
    2955842-2014-04293
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 18, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT THE DRIVE CABLE WAS FRAYED. THE PITCH UP CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE UNDAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE DAMAGED CABLE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PK DISSECTING FORCEPS INSTRUMENT WIRE THAT CONTROLS THE TIPS WAS STICKING OUT, IT WAS NOTED TO BE FRAYED DURING A DA VINCI HYSTERECTOMY PROCEDURE. NO FRAGMENTS FELL INTO THE 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
    412370 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-05 N10140424 131

    Patients

    Seq Age Sex Outcome Treatment
    1