BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3123474 · Received May 22, 2013

    Report

    Report Number
    2955842-2013-01770
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 23, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND WITH A FRAYED PITCH CABLE AT DISTAL CLEVIS. NO DAMAGE WAS FOUND ON THE PULLEY AND CLEVIS. ADDITIONAL DAMAGE FOUND WAS A CORRODED BACK IDLER PULLEY. ON THE SURFACE OF EACH PULLEY EXHIBITED A YELLOWISH MATERIAL. ENGINEERING CONCLUDED THE DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. ELECTRICAL CONTINUITY PASSED. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: WARNING: READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW INSTRUCTIONS MAY CAUSE IMPROPER FUNCTIONING OF THE DEVICE. 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 TOTAL BENIGN HYSTERECTOMY PROCEDURE A BROKEN CABLE WAS IDENTIFIED ON A MARYLAND BIPOLAR FORCEPS INSTRUMENT. 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
    225976 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10121215 886

    Patients

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