BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO BIPOLAR FORCEPS INSTRUME

    MDR report key: 3143475 · Received June 3, 2013

    Report

    Report Number
    2955842-2013-01957
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 15, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. RECEIVED THE INSTRUMENT INVOLVED WITH THE COMPLAINT. THE CUSTOMER INITIALLY REPORTED THAT THE GRIPS WILL NOT STAY CLOSED. HOWEVER FOR CLARIFICATION, THE NONCONFORMANCE WAS NON-INTUITIVE MOTION. BASED ON THIS, THE COMPLAINT WAS CONFIRMED. INTUITIVE MOTION WAS NOT BEING EXPERIENCED DUE TO A BROKEN PITCH CABLE AT THE INSTRUMENT'S WRIST. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    DURING A DA VINCI SI ESOPHAGEAL DIVERTICULUM REPAIR PROCEDURE, THE USER FACILITY REPORTEDLY IDENTIFIED THE GRIPS WERE NOT STAYING CLOSED ON THE MICRO BIPOLAR FORCEPS INSTRUMENT. NOTHING REPORTEDLY FELL INTO A PATIENT. 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
    243693 MICRO BIPOLAR FORCEPS INSTRUME ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420171-05 M10081020 077

    Patients

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