BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG TIP FORCEPS

    MDR report key: 2822851 · Received November 7, 2012

    Report

    Report Number
    2955842-2012-00808
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE GRIP CABLE WAS FOUND TO BE FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STICK OUT AT THE WRIST. NO OTHER DAMAGE 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 S HYSTERECTOMY PROCEDURE, THE CUSTOMER NOTED THAT FRAYED WIRES WERE STICKING OUT AT THE DISTAL END OF THE LONG TIP FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG TIP FORCEPS ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420048-06 M10120418 928

    Patients

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