BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 4173475 · Received October 15, 2014

    Report

    Report Number
    2955842-2014-05487
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 24, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S PITCH CABLE WAS BROKEN AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. BROKEN STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ISI HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE AND DID NOT FIND ANY NON-CONFORMANCES THAT WERE RELATED TO THIS REPORTED EVENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN PITCH CABLE IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN CENTRAL PROCESSING THAT A BROKEN CABLE WAS OBSERVED ON THE TENACULUM FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653528 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420207-06 M10110204 567

    Patients

    Seq Age Sex Outcome Treatment
    1