BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3201779 · Received July 2, 2013

    Report

    Report Number
    2955842-2013-02392
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE CUSTOMER WERE PULLEY AND MAIN TUBE DAMAGES. THERE WERE INDENTATIONS ON THE EDGE OF THE DISTAL PULLEY AND SCRATCHES ON THE SURFACE OF THE PULLEY. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCHES SHOWING LIGHT MATERIAL REMOVAL. SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. EVIDENCE NOT CONCLUSIVE, BUT PULLEY AND MAIN TUBE DAMAGE MAY BE DUE TO MISHANDLING. THE INSTRUMENTS & ACCESSORIES INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS -HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. 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 DA VINCI SI HYSTERECTOMY PROCEDURE, THE USER FACILITY IDENTIFIED A BROKEN WIRE ON THE PROGRASP 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
    302977 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10130118 062

    Patients

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