BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 2832869 · Received November 14, 2012

    Report

    Report Number
    2955842-2012-00938
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 17, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. CUSTOMER INITIALLY REPORTED BROKEN CABLE. HOWEVER FOR CLARIFICATION, THE PRODUCT PROBLEM WAS A FRAYED PITCH CABLE. BASED ON THIS, THE COMPLAINT WAS CONFIRMED. FRAYED PITCH CABLE WAS FOUND AT DISTAL CLEVIS HUB. FRAYED SEGMENT ARE VARIOUS IN LENGTH. 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 AFTER A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF REPORTED SEEING A BROKEN CABLE ON THE PK DISSECTING FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M11120904 193

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES