BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 2853436 · Received November 30, 2012

    Report

    Report Number
    2955842-2012-01142
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER 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 INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(4) 2012, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. THE CSR INDICATED THAT SHE WAS PRESENT DURING THE PLANNED SURGICAL PROCEDURE AND THAT THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH THE MCS TIP COVER ACCESSORY INSTALLED WAS REMOVED SIMULTANEOUSLY WITH THE CANNULA TO ALLOW FOR REMOVAL OF THE MCS INSTRUMENT FROM THE PATIENT. THE CSR INDICATED THAT THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED EVENT. THE CSR INDICATED THAT THE PLANNED SURGICAL PROCEDURE WAS COMPLETED USING OPEN SURGICAL TECHNIQUES DUE TO THE SIZE AND DEGENERATIVE STATE OF THE PATIENT'S FIBROIDS. THE CSR INDICATED THAT ONE OF THE FIBROIDS WAS 13 CENTIMETERS AND HAD DEGENERATED, MAKING IT VERY DIFFICULT FOR THE SURGEON TO REMOVE IT USING THE DA VINCI SURGICAL SYSTEM. THE CSR INDICATED THAT THE PATIENT REQUIRED A BLOOD TRANSFUSION OF 1 TO 2 PINTS OF BLOOD AS A RESULT OF BLOOD LOSS THAT OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR INDICATED A WEEK LATER, SHE FOLLOWED UP WITH THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE REGARDING THE STATUS OF THE PATIENT. PER THE CSR, THE SURGEON INDICATED THAT THE PATIENT WAS RECOVERING WELL. ON (B)(4) 2012, ISI CONTACTED, RN (B)(6). (B)(6) INDICATED THAT THE MCS TIP COVER ACCESSORY IS NOT AVAILABLE FOR RETURN TO ISI FOR EVALUATION AS IT WAS DISCARDED. (B)(6) INDICATED THAT THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS. AS OF (B)(4) 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S MYOMECTOMY PROCEDURE, THE SITE WAS UNABLE TO REMOVE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH THE MCS TIP COVER ACCESSORY INSTALLED FROM THE PATIENT SIDE MANIPULATOR (PSM) ARM 2. INSPECTION OF THE MCS INSTRUMENT BY THE SURGICAL STAFF FOUND THAT THE TIP COVER SLID DOWN OVER THE INSTRUMENT WRIST, PREVENTING REMOVAL OF THE INSTRUMENT FROM THE CANNULA. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-12

    Patients

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