BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 2950328 · Received February 8, 2013

    Report

    Report Number
    2955842-2013-00432
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING FOUND THE INSTRUMENT TO HAVE A LOOSE AND FRAYED PITCH CABLE AT THE DISTAL CLEVIS HUB. THE PITCH CABLE WAS ALSO FOUND DERAILED AT THE IDLER BLOCK. ENGINEERING ALSO FOUND CHEMICAL RESIDUES ON THE CLAMPING PULLEY AND CABLE. ENGINEERING CONCLUDED THAT THE RESIDUE WAS LIKELY DUE TO IMPROPER CLEANING OF THE INSTRUMENT. THE CLEANING AND STERILIZATION USER MANUAL SPECIFICALLY STATES: WHEN SCRUBBING THE TIP OF CAUTERY INSTRUMENTS, TAKE CARE NOT TO DAMAGE THE INSULATION. DO NOT EXPOSE INSTRUMENTS TO HYDROGEN PEROXIDE (H2O2), BLEACH, OR ALKALINE-BASED CLEANING AGENTS, AS THIS MAY RESULT IN INSTRUMENT DAMAGE. PROLONGED EXPOSURE TO EITHER ULTRASONIC CLEANING OR CLEANING AGENTS MAY RESULT IN INSTRUMENT DAMAGE. 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 TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF ALLEGED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WOULD NOT ROTATE. THERE WERE NO MISSING 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
    53901 MARYLAND BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10110228 003

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURGICAL SYSTEM, ACCESSORIES, AND ESU