BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADIERE FORCEPS INSTRUMENT

    MDR report key: 2980871 · Received February 27, 2013

    Report

    Report Number
    2955842-2013-00647
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    December 3, 2012
    Report Date
    January 29, 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. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING EVALUATION FOUND THAT THE NONCONFORMANCE WAS A BROKEN GRIP CABLE. THE INTUITIVE MOTION WAS NOT BEING EXPERIENCED BECAUSE THE GRIP CABLE WAS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPUN FREELY AND EXHIBITED RIM PULLEY DAMAGE. THE CABLE SEGMENT STUCK OUT AT THE WRIST. 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 PRIOR TO STARTING A DA VINCI S SURGICAL PROCEDURE THAT THE CADIERE FORCEPS INSTRUMENT TIP DID NOT WORK. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84597 CADIERE FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420049-06 M10120229 142

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI S SYSTEM, INSTRUMENTS & ACCESSORIES