BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3002992 · Received March 13, 2013

    Report

    Report Number
    2955842-2013-00826
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE AS FUNCTIONAL TESTING OF THE INSTRUMENT FOUND THAT IT SUCCESSFULLY PASSED RECOGNITION TESTING ON AN IS3000 IN-HOUSE SYSTEM. FUNCTIONAL TESTING ALSO FOUND THAT THE INSTRUMENT HAD 3 USES REMAINING. THE POGO PINS DID NOT STICK AND WERE NOT CONTAMINATED. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING EVALUATION ALSO FOUND THAT THE PITCH CABLE AT THE DISTAL CLEVIS HUB WAS BROKEN. THE CABLE SEGMENT THAT CONTAINS THE CRIMP REMAINED INSTALLED IN THE CLEVIS AND THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE PK DISSECTING FORCEPS INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. REPORTEDLY, DURING REPROCESSING OF THE INSTRUMENT, THE CABLE WAS NOTED TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106121 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120510 953

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYS, INSTRUMENTS, ACCESSORIES & ESU