BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE (TM) BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3000578 · Received March 12, 2013

    Report

    Report Number
    2955842-2013-00800
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND WITH A FRAYED PITCH CABLE LOCATED AT DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. FRAYED SEGMENT WAS APPROXIMATELY 0.03 IN LENGTH. NO OTHER CABLE DAMAGE WAS FOUND. 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

    IT WAS REPORTED THAT DURING A DAVINCI SI PROSTATECTOMY PROCEDURE, THE CUSTOMER NOTED THAT THE CLAMP WAS DISLOCATED AT THE BASE OF THE PRECISE BIPOLAR FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104038 PRECISE (TM) BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420110-06 M10120706 825

    Patients

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