BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACK DIAMOND MICRO FORCEPS INSTRUMENT

    MDR report key: 4250971 · Received November 14, 2014

    Report

    Report Number
    2955842-2014-05672
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 17, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THE PITCH DOWN CABLE BROKEN AT THE DISTAL CLEVIS, CABLE SEGMENT STUCK OUT AT THE WRIST. 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 ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; BROKEN PITCH CABLE, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE CABLE WAS BROKEN ON THE BLACK DIAMOND MICRO FORCEPS INSTRUMENT. THERE WAS NO ALLEGATION OF HARM OR INJURY OR REPORTS OF FRAGMENTS FALLING INTO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736210 BLACK DIAMOND MICRO FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420033-06 M10120409 946

    Patients

    Seq Age Sex Outcome Treatment
    1