BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE (TM) BIPOLAR FORCEPS

    MDR report key: 2882369 · Received December 20, 2012

    Report

    Report Number
    2955842-2012-01386
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE PITCH CABLES WERE BROKEN AT THE DISTAL CLEVIS HUB. A CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING AND NO LONGER IN THE CLEVIS. THE CLEVIS DOES NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE INSTRUMENT HAS 6 USES REMAINING. INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. ON (B)(6) 2012, THE REPORT OF THIS COMPLAINT RETURNED THE CALL AND STATED THAT NO FRAGMENTS FELL INTO THE PATIENT AND NO INJURIES HAD OCCURRED. THE MISSING FRAGMENT COULD HAVE FALLEN OFF DURING CLEANING OR SHIPPING. NO FURTHER INFORMATION WAS AVAILABLE. 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 SI SURGICAL PROCEDURE, THE CABLE OF THE PRECISE BIPOLAR FORCEPS INSTRUMENT BROKE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE (TM) BIPOLAR FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420110-06 M10111201 909

    Patients

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