BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 3882284 · Received June 18, 2014

    Report

    Report Number
    2955842-2014-03761
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    April 29, 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 Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS CONFIRMED THE REPORTED COMPLAINT. THE PITCH CABLE WAS FRAYED AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. AN ADDITIONAL OBSERVATION NOT REPORTED WAS THE TIPS OF THE INSTRUMENTS GRIPS WERE BENT. ONE GRIP WAS BENT, CAUSING A SIDE TO SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A .020 OFFSET AT THE TIP. THE BENT GRIP EXHIBITED SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT INDICATING OVERLOADING AT THE TIP. FAILURE ANALYSIS CONCLUDED THE DAMAGE MAY BE DUE TO MISHANDLING / MISUSE. THE ENDOWRIST® INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE EXHIBITING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE NOT AXIALLY ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE FRAYED CABLE AND THE ADDITIONAL FINDING OF TUBE ABRASIONS WITH MATERIAL REMOVED, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, ONE OF THE CABLES WAS OBSERVED TO BE DAMAGED ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THE INSTRUMENT WAS NOT USED ON THE PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED. NOTHING REPORTEDLY FELL INTO A PATIENT AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358711 MARYLAND BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10131130 449

    Patients

    Seq Age Sex Outcome Treatment
    1