BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAP-FIT PADDLE BLADE ACCESSORY

    MDR report key: 3250889 · Received July 29, 2013

    Report

    Report Number
    2955842-2013-02786
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K990144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ACCESSORY 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 ACCESSORY IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. SHE INDICATED THAT THE SNAP-FIT PADDLE BLADE FELL OFF THE INSTRUMENT AND INTO THE PATIENT. SHE DENIED THAT THE BLADE BROKE OFF. THE BLADE WAS RETRIEVED VIA A LAPAROSCOPIC ASSIST PORT. THE INITIAL REPORTER DENIED THAT AN X-RAY WAS PERFORMED DUE TO THE REPORTED EVENT. SHE ALSO DENIED THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS BECAUSE OF THE REPORTED ISSUE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGICAL STAFF INDICATED THAT THE SNAP-FIT PADDLE BLADE INSTRUMENT ACCESSORY BECAME DISLODGED FROM THE INSTRUMENT, FELL INTO THE PATIENT, AND WAS RETRIEVED. AT THIS TIME, THERE IS NO INDICATION THAT THE PATIENT WAS HARMED OR INJURED BECAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF INDICATED THAT THE SNAP-FIT PADDLE BLADE INSTRUMENT ACCESSORY INSTALLED ON A SNAP-FIT SCALPEL INSTRUMENT BECAME DISLODGED AND FELL INTO THE PATIENT. AT THE TIME THE BLADE BECAME DISLODGED, THE SURGEON WAS CUTTING THE PATIENT'S UTERUS. THE SURGEON WAS ABLE TO RETRIEVE THE INSTRUMENT ACCESSORY USING A LAPAROSCOPIC GRASPER INSTRUMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353302 SNAP-FIT PADDLE BLADE ACCESSORY ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400158-01 MBKH740

    Patients

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