BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAP-FIT BLUE BLADE ACCESSORY

    MDR report key: 2853539 · Received December 3, 2012

    Report

    Report Number
    2955842-2012-01143
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SNAP-FIT BLUE BLADE ACCESSORY WAS HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ON NOVEMBER 5, 2012, AN ISI FIELD SERVICE ENGINEER FOLLOWED-UP WITH THE SITE CONCERNING THE REPORTED EVENT. THE FSE WAS UNABLE TO EVALUATE THE SYSTEM SINCE IT WAS BEING USED DURING A SURGICAL PROCEDURE; HOWEVER, THE FSE CONFIRMED WITH THE SITE'S DA VINCI COORDINATOR THAT THEIR DA VINCI SI SURGICAL SYSTEM WAS PERFORMING NORMALLY. AS OF (B)(4) 2012 THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL RECEIVED ADDITIONAL INFORMATION FROM THE INITIAL REPORTER REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE SURGEON WAS ATTEMPTING TO REMOVE A MYOMA FROM THE PATIENT'S UTERUS, THE SNAP-FIT-BLADE INSTALLED ON THE SNAP-FIT SCALPEL INSTRUMENT BROKE OFF AND WAS STUCK IN THE MYOMA. THE INITIAL REPORTER INDICATED THAT THE BLADE WAS REMOVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THE BLADE ACCESSORY WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI MYOMECTOMY PROCEDURE, DURING MORCELLATION, THE SNAP-FIT BLUE BLADE ACCESSORY INSTALLED ON THE SNAP-FIT SCALPEL INSTRUMENT FELL INTO THE PATIENT. THE BLADE ACCESSORY WAS SUCCESSFULLY RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SNAP-FIT BLUE BLADE ACCESSORY ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400152

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYS., SNAP-FIT SCALPEL INST & ACCSS.