BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS

    MDR report key: 2970495 · Received February 20, 2013

    Report

    Report Number
    2955842-2013-00559
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 22, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT A WIRE WAS DAMAGED AT THE WRIST. THE INSTRUMENT WAS FOUND WITH FRAYED CABLES ALONG THE PROXIMAL AND DISTAL AREA. FOUR FRAYED CABLE STRANDS WERE STICKING OUT. NO DAMAGE WAS FOUND ON PULLEY AND CLEVIS AREA. 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 HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A DAMAGED WIRE AT THE WRIST. THE INSTRUMENT WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74311 FENESTRATED BIPOLAR FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10121107 547

    Patients

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