BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCSTIP COVER

    MDR report key: 2855078 · Received December 3, 2012

    Report

    Report Number
    2955842-2012-01152
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    August 14, 2012
    Report Date
    August 14, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE REPORTED FAILURE MODE. VISUAL INSPECTION SHOWED NO DAMAGE TO THE MCS TIP COVER. THE MCS TIP COVER WAS INSTALLED ON THE IN-HOUSE MONOPOLAR CURVED SCISSORS INSTRUMENT AND IT WAS A SNUG FIT OVER THE MONOPOLAR CURVED SCISSORS INSTRUMENT TUBE EXTENSION. THE MCS TIP COVER DID NOT FALL OUT WHILE THE MCS INSTRUMENT WAS DRIVEN ON THE IN-HOUSE DAVINCI ROBOTIC SYSTEM. ONE POSSIBLE METHOD OF TIP COVER COMING OFF COULD BE DURING INSTRUMENT REMOVAL FROM THE CANNULA. THIS FAILURE IS TYPICALLY ONLY ABLE TO BE REPLICATED WHEN THE TIP COVER IS OVER-INSTALLED PAST THE SHOULDER OF THE MONOPOLAR CURVED SCISSORS TUBE EXTENSION. NO PHYSICAL DAMAGE FOUND ON THE MCS TIP COVERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI SI HYSTERECTOMY PROCEDURE, THE MCS TIP COVER ACCESSORY THAT IS USED WITH THE MONOPOLOAR CURVED SCISSORS INSTRUMENT, SLIPPED OFF THE INSTRUMENT WHILE IN ABDOMEN AND FELL INSIDE THE PATIENT. THE MCS TIP COVER WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A NEW MCS TIP COVER. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8MM MCSTIP COVER ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 400180-12 M10120507

    Patients

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