BEUDAMED
    FDA Adverse Event Other Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1023503 · Received March 28, 2008

    Report

    Report Number
    2955842-2008-00170
    Event Type
    Other
    Date Received
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MSC INSTRUMENT AND TIP COVER ACCESSORY WERE RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE ULTEM SLEEVE PORTION OF THE TIP COVER WAS MISSING; THE RETURNED SILICONE SECTION HAD BEEN CUT OFF NEAR THE INTERFACE BETWEEN THE TWO MATERIALS. THE SILICONE HAD FOUR DISTINCT HOLES BURNED THROUGH IT, ALL OF WHICH EXHIBIT LOCALIZED MELTING CONSISTENT WITH ELECTRICAL ARCING. HOLES ARE OBLONG AND HEART SHAPED, WITH ONE LOCATED AT ONE PARTING LINE AND THE OTHER THREE HOLES ADJACENT TO EACH OTHER, ROUGHLY 90 DEGREES FROM THE FIRST HOLE. SEVERE TEARS/SCRATCHES ON THE SILICONE WERE FOUND NEAR THE THREE HOLES, INDICATING POSSIBLE INSTRUMENT COLLISIONS. FURTHER, SEVERAL MECHANICAL TEARS WERE FOUND AT THE DISTAL END OF THE SILICONE, HOWEVER, IT CAN NOT BE DETERMINED IF THESE TEARS CONTRIBUTED TO THE ARCING. THE INSTRUMENT CONTAINED SEVERAL CHAR SPOTS ON THE DISTAL CLEVIS AND EAR OF THE PROXIMAL CLEVIS, FURTHER SUGGESTING ARCING WAS THE FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEAR THE END OF A VINCI TOTAL HYSTERECTOMY SURGICAL PROCEDURE, THE SURGEON HAD THE WRIST OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT AT A 90 DEGREE ANGLE WHILE COMPLETING THE POSTERIOR CUFF OF THE COLPOTOMY (REMOVAL OF THE UTERUS FROM VAGINA). AFTER A BRIEF PERIOD, THE SURGEON NOTICED SPARKS COMING OUT OF THE WRIST OF THE INSTRUMENT. UPON FURTHER INSPECTION, A HOLE IN THE MCS TIP COVER ACCESSORY WAS DISCOVERED. FURTHER, A BURN MARK WAS OBSERVED ON THE PT'S UTERUS THAT WAS ALREADY BEING REMOVED. THE TIP COVER WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW TIP COVER. USING THE SAME INSTRUMENT, THE PLANNED PROCEDURE WAS COMPLETED WITH NO DELAY. NO ADD'L PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8MM MCS TIP COVER ACCESSORY ELECTROSURGICAL INSTRUMENT ACCESSORY GEI INTUITIVE SURGICAL, INC. 400180-05 C8011

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other DA VINCI SURGICAL SYSTEM| MCS INSTRUMENT| A CANNULA ACCESSORY| AN ELECTROSURGICAL UNIT.