BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 MM MCS TIP COVER ACCESSORY

    MDR report key: 2893871 · Received January 2, 2013

    Report

    Report Number
    2955842-2013-00010
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 3, 2012
    Report Date
    January 15, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. IT WAS INDICATED THAT THE TIP COVER ACCESSORY WAS RETRIEVED AND THERE WAS NO HARM OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED AND THE PATIENT HAS RECOVERED AS EXPECTED WITHOUT ANY POST-SURGICAL COMPLICATIONS. THE ACCESSORY HAS 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.

    Additional Manufacturer Narrative · 1

    THE ACCESSORY WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT THAT THE TIP COVER WAS TOO LARGE. VISUAL INSPECTION SHOWED NO SCRATCHES, TEARS, OR SIGNS OF ARCING ON THE TIP COVER. COMPARED WITH ANOTHER MCS TIP COVER -12, TIP COVER SHOWED NO ABNORMALITIES IN SIZE. THE TIP COVER WAS INSTALLED ON A MONOPOLAR CURVED SCISSORS INSTRUMENT AND IT FIT SNUGLY. THE INSTRUMENT WAS DRIVEN ON THE SYSTEM AND THE TIP COVER DID NOT FALL OFF. ENGINEERING WAS UNABLE TO MAKE THIS TIP COVER SLIP OFF THE MONOPOLAR CURVED SCISSORS WHEN INSTALLED CORRECTLY. NO PHYSICAL DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: WARNING: FAILURE TO INSTALL THE TIP COVER ACCESSORY PROPERLY MAY RESULT IN: IMPROPER SCISSOR OPENING, TIP COVER ACCESSORY FALLING OFF, ELECTRICAL ARCS AND ALTERNATE SITE BURNS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI SI SACROPOLPEXY SURGERY THAT THE TIP COVER ACCESSORY WAS TOO LARGE AND SLIPPED OFF INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-12 M11121011

    Patients

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