BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 4223562 · Received November 4, 2014

    Report

    Report Number
    2955842-2014-05589
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND A BROKEN PITCH CABLE AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. THE BROKEN STRANDS STUCK OUT AT THE INSTRUMENTS' WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE BROKEN PITCH CABLE FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CABLE ON THE PK DISSECTING FORCEPS INSTRUMENT CAME LOOSE IN THE BOTTOM AND THE DA VINCI ROBOT DID NOT ACCEPT IT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706569 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-05 N10140704 388

    Patients

    Seq Age Sex Outcome Treatment
    1