BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8 MM MCS TIP COVER ACCESSORY

    MDR report key: 3090826 · Received May 2, 2013

    Report

    Report Number
    2955842-2013-01514
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    October 19, 2012
    Report Date
    April 2, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY HAS NOT BEEN RETURNED TO ISI 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, ISI CONTACTED THE INITIAL REPORTER REGARDING THE REPORTED EVENT. THE REPORTER INDICATED THAT PRIOR TO USE THE TIP COVER WAS INSPECTED. HOWEVER, SHE INDICATED THAT SHE DID NOT KNOW IF THE INSTALLATION TOOL WAS USED TO INSTALL THE TIP COVER ONTO THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT OR IF ELECTROLUBE WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO INSTALLATION OF THE TIP COVER ONTO THE MCS INSTRUMENT. THE INITIAL REPORTER WAS UNABLE TO CONFIRM IF THE MCS INSTRUMENT MADE CONTACT WITH ANY OTHER INSTRUMENT DURING THE SURGICAL PROCEDURE OR IF THE MCS INSTRUMENT WAS REMOVED AT ANY TIME DURING THE SURGICAL PROCEDURE. PER THE INITIAL REPORTER, THERE WAS NO REPORT BY THE SURGICAL STAFF THAT A MALFUNCTION OF THE INSTRUMENT OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER INDICATED THAT A CT SCAN PERFORMED ON THE PATIENT REVEALED THAT THE PATIENT HAD RETAINED THE TIP COVER ACCESSORY AND THAT THE PATIENT WAS RETURNED TO THE OPERATING ROOM THE SAME DAY FOR REMOVAL OF THE TIP COVER ACCESSORY. THE TIP COVER WAS REMOVED LAPAROSCOPICALLY. THE INITIAL REPORTER INDICATED THAT THE PATIENT RECOVERED AS PLANNED AND WAS STABLE UPON DISCHARGE FROM THE HOSPITAL. THE REPORTER INDICATED THAT THE TIP COVER ACCESSORY AND MCS INSTRUMENT WERE NOT AVAILABLE FOR RETURN TO ISI FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED UF IMPORTER REPORT (B)(4) FROM THE FDA WITH THE FOLLOWING EVENT DESCRIPTION: UPON CLOSING THE PATIENT, IT WAS REPORTED THAT A CAP FROM THE MONOPOLAR SCISSORS WAS MISSING. PATIENT REQUIRED A RETURN TO THE OPERATING ROOM (OR) FOR REMOVAL AFTER TIP WAS LOCATED BY A COMPUTED TOMOGRAPHY (CT) SCAN. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? TOTAL LAPAROSCOPIC HYSTERECTOMY WITH DAVINCI ASSIST DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192367 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-12

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI SI SURG SYS INST., ACCESSORIES, & ESU