BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 2022593 · Received March 17, 2011

    Report

    Report Number
    2955842-2011-00080
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY AND MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAVE NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, ARCING WAS OBSERVED COMING FROM THE MONOPOLAR CURVED SCISSORS (MCS) WITH A MCS TIP COVER ACCESSORY INSTALLED. A SMALL THERMAL INJURY WAS OBSERVED ON THE PATIENT'S BOWEL AND WAS REPAIRED VIA STITCH. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT MCS INSTRUMENT TIP COVER ACCESSORY. NO PATIENT RECOVERED WELL WITH NO POST OPERATIVE COMPLICATIONS OR PROLONGED HOSPITALIZATION. THE DELAY OF THIS REPORT IS DUE TO THE SITE'S INITIAL REPORTER GOING OUT ON MEDICAL LEAVE PRIOR TO SUBMITTING THE REPORT AS INITIALLY INTENDED. UPON HER RETURN, SEVERAL WEEKS LATER, THE REPORT WAS FILED. AN ISI REPRESENTATIVE WAS ONSITE DURING THE PROCEDURE; HOWEVER, BELIEVED THE INITIAL REPORTER WOULD INITIATE THE COMPLAINT RECORD WITH ISI CUSTOMER SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8MM MCS TIP COVER ACCESSORY ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-10 C10284

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG SYS, MCS INSTRUMENT, ACCSS, ESU