BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS

    MDR report key: 2870071 · Received December 10, 2012

    Report

    Report Number
    2955842-2012-01232
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 12, 2012
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH UP CABLE WAS FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. NO OTHER DAMAGE FOUND. 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 SI COLECTOMY PROCEDURE, THE CUSTOMER NOTED "FRAYED CABLES AT THE DISTAL END, NOTHING FELL IN PATIENT OR HARM" ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENESTRATED BIPOLAR FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT, NAY NAY INTUITIVE SURGICAL, INC. 420205-05 M10120913 029

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES