BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 3103318 · Received May 9, 2013

    Report

    Report Number
    2955842-2013-01573
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MCS TIP COVER ACCESSORY WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION FOUND NO DAMAGE WITH MCS TIP COVER ACCESSORY. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION WAS UNABLE TO CONFIRM THE ALLEGED ISSUE OF AN UNSEALED MCS TIP COVER ACCESSORY PACKAGE. THE MCS TIP COVER ACCESSORY WAS RETURNED TO ISI WITHOUT THE PACKAGE THAT WAS REPORTEDLY UNSEALED. ENGINEERING WAS UNABLE TO CONFIRM IF THE MCS TIP COVER ACCESSORY PACKAGE WAS SEALED OR NOT ALTHOUGH A PHOTOGRAPH OF AN UNSPECIFIED PACKAGE WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SETUP OF A DA VINCI S PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF FOUND AN UNSEALED PACKAGE OF A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THE MCS TIP COVER ACCESSORY WAS NOT USED IN THE SURGICAL PROCEDURE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AS PLANNED USING AN MCS TIP COVER ACCESSORY FROM A NEW PACKAGE. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203678 8MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-10 C12072

    Patients

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