BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 2851839 · Received November 29, 2012

    Report

    Report Number
    2955842-2012-01108
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 31, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    GEI
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF WIRES ON TIP OF INSTRUMENT ARE LOOSE IS CONFIRMED. THE PITCH UP CABLE IS BROKEN AT THE DISTAL CLEVIS HUB. CABLE SEGMENT THAT CONTAINS THE CRIMP IS STILL INSTALLED IN CLEVIS. CLEVIS DOES NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT WRIST ARE NOT DAMAGED. NO OTHER DAMAGE FOUND. 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 S SURGICAL PROCEDURE, DURING SET UP, THE SURGICAL STAFF REPORTED SEEING LOOSE WIRES AT THE TIP OF THE TENACULUM FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GEI INTUITIVE SURGICAL,INC. 420207-06 M10111007 412

    Patients

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