BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2983728 · Received February 28, 2013

    Report

    Report Number
    2955842-2013-00671
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 29, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND WITH A BROKEN PITCH CABLE AT THE WRIST. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE CABLE CRIMP REMAINED IN THE CLEVIS. ENGINEERING CONCLUDED THAT THE NON-INTUITIVE MOTION WAS PROBABLY CAUSED BY THE BROKEN PITCH CABLE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI S SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE FENESTRATED BIPOLAR INSTRUMENT WAS UNABLE TO ROTATE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87628 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10120905 347

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES