BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1161192 · Received September 12, 2008

    Report

    Report Number
    2955842-2008-01265
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCESSORY AND INSTRUMENT HAVE NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF THE ACCESSORY OR INSTRUMENT ARE RETURNED FOR EVALUATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, WHILE USING THE MONOPOLAR CURVED SCISSORS INSTRUMENT (MCS) WITH THE TIP COVER ACCESSORY INSTALLED, THE SURGEON NOTICED ARCING AND A BURN ON THE PATIENT'S BOWEL. THE PROCEDURE WAS CONVERTED TO A MINI LAPARATOMY TO REPAIR THE BOWEL. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND REQUIRED ADDITIONAL HOSPITALIZATION, DUE TO THE BOWEL INJURY. NO ADDITIONAL PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE ATTENDING PHYSICIAN PRESENT FOR THIS PROCEDURE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O AND AN ELECTROSURGICAL UNIT| DA VINCI S SURGICAL SYSTEM| MONOPOLAR CURVED SCISSORS INSTRUMENT