BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3243977 · Received July 23, 2013

    Report

    Report Number
    2955842-2013-02705
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    April 9, 2013
    Report Date
    June 26, 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. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND WITH A FRAYED PITCH CABLE AT THE DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. THE FRAYED SEGMENT WAS APPROXIMATELY 0.03 IN LENGTH. NO OTHER CABLE DAMAGE WAS FOUND. 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 DURING A DA VINCI SI PROSTATECTOMY PROCEDURE A SURGEON WAS COMPLAINING THAT THE GRASPER WAS NOT HOLDING TISSUE. THE SURGICAL ASSISTANT REMOVED THE FORCEPS AND A SCRUB NURSE INSPECTED IT NOTING SMALL WIRES WERE FRAYING. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. 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
    344047 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10121022 926

    Patients

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