BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3830888 · Received May 23, 2014

    Report

    Report Number
    2955842-2014-03206
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 21, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S GRIP TIPS TO BE BENT. ONE GRIP WAS BENT WHICH CAUSED SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A .045 OFFSET AT THE TIPS. THE BENT GRIP EXHIBITED SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, INDICATING LIKELY CAUSE OF BENDING REMAINS OVERLOADING AT THE TIP. FAILURE ANALYSIS CONCLUDED THAT THE BENT DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT THE TIPS WERE BENT ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307452 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10131104 906

    Patients

    Seq Age Sex Outcome Treatment
    1