BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2841100 · Received November 20, 2012

    Report

    Report Number
    2955842-2012-01018
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 22, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH CABLE AT THE DISTAL CLEVIS HUB IS FRAYED. NO DAMAGE WAS FOUND AT THE CLEVIS. THE FRAYED SEGMENT IS 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 AFTER COMPLETION OF A DA VINCI S HYSTERECTOMY PROCEDURE, WHILE PERFORMING THE SURGICAL STAFF OBSERVED THAT THE WIRE AT THE TIP OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS JAGGED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10110928 831

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SURG SYSTEM, ACCESSORIES AND ESU