BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1932274 · Received December 17, 2010

    Report

    Report Number
    2955842-2010-00552
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 24, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MCS TIP COVER ACCESSORY HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF THE TIP COVER IS RETURNED FOR EVALUATION A FOLLOW-UP MDR WILL BE SUBMITTED. THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PROXIMAL CLEVIS EXHIBITS A SERIES OF CHAR MARKS FROM APPROXIMATELY .100 TO .140 ABOVE THE INTERFACE WITH THE TUBE EXTENSION. ENGINEERING CONCLUDED THAT THE CHAR MARKS ARE MOST LIKELY THE AREAS WHERE ENERGY ESCAPED THROUGH THE TIP COVER. ALTHOUGH THE MCS TIP COVER ACCESSORY USED IN CONJUNCTION WITH THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS NOT RETURNED FOR EVALUATION, ENGINEERING FOUND THAT THE CHAR MARKS ON THE INSTRUMENT ARE LOCATED WHERE THE TIP COVER ACCESSORY SILICONE AND ULTEM SLEEVE MEET. THERE ARE NO BURRS/DAMAGE ON THE INSTRUMENT IN THE AREA WHERE THE CHAR MARKS ARE LOCATED THAT WOULD CONTRIBUTE TO AN ARCING EVENT. NO OTHER DAMAGE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, ARCING WAS OBSERVED COMING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH AN MCS TIP COVER ACCESSORY INSTALLED. 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
    1 8MM MCS TIP COVER ACCESSORY ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SURG SYS, ACCSS, MCS INSTRUMENT, ESU