BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3891912 · Received June 24, 2014

    Report

    Report Number
    2955842-2014-03861
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE PITCH CABLE WAS FRAYED AT THE PROXIMAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE CLEVIS DID NOT EXHIBIT ANY WEAR. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE FRAYED CABLE 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, A FRAYED CABLE WAS IDENTIFIED ON THE PK DISSECTING FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A 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
    368369 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 N10140124 460

    Patients

    Seq Age Sex Outcome Treatment
    1