BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPSINSTRUMENT

    MDR report key: 2944459 · Received February 5, 2013

    Report

    Report Number
    2955842-2013-00366
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 7, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE ALLEGED COMPLAINT OF THAT THE INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM COULD NOT BE CONFIRMED. THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IN-HOUSE IS3000 SYSTEM. THE IS3000 SYSTEM SUCCESSFULLY RECOGNIZED THE INSTRUMENT. THE POGO PINS OF THE INSTRUMENT WERE NOT FOUND TO BE STICKING AND WERE NOT CONTAMINATED. ENGINEERING WAS UNABLE TO REPLICATE THE ALLEGED RECOGNITION ISSUE. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS A BROKEN CABLE. THE PITCH DOWN CABLE WAS FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT THE INSTRUMENT'S WRIST WERE NOT DAMAGED. NO OTHER INSTRUMENT DAMAGE WAS OBSERVED. 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 A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF ALLEGED THAT THE PK DISSECTING FORCEPS INSTRUMENT HAD A RECOGNITION ISSUE WITH THE SYSTEM. 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
    47884 PK DISSECTING FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M11120524 939

    Patients

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