BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 MM MCS TIP COVER ACCESSORY

    MDR report key: 2970563 · Received February 20, 2013

    Report

    Report Number
    2955842-2013-00564
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 24, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT 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. ON (B)(4) 2013, ISI CONTACTED THE NURSING CLINICAL LEADER FOR ROBOTIC SURGERY AT THE SITE AND OBTAINED ADDITIONAL INFORMATION. SHE INDICATED THAT THE ACCESSORY, INSTRUMENT, AND CANNULA WERE INSPECTED PRIOR TO USE. TO HER KNOWLEDGE, SHE ALSO INDICATED THAT THE MCS TIP COVER ACCESSORY WAS INSTALLED USING THE ISI INSTALLATION TOOL. SHE DENIED THAT ELECTROLUBE WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO INSTALLING THE MCS TIP COVER ACCESSORY. SHE DENIED THAT ELECTROLUBE WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO INSTALLING THE MCS TIP COVER ACCESSORY. SHE DENIED THAT THE EVENT WAS RECORDED, THAT THE PATIENT WAS INJURED AS A RESULT OF THE ALLEGED ARCING ISSUE, THAT ANY POST-OPERATIVE COMPLICATIONS OCCURRED, OR THAT ANY INSTRUMENTS WERE REMOVED AT ANY TIME PRIOR TO THE ARCING EVENT. SHE ALSO MENTIONED THAT THE SITE USES VALLEYLAB FORCE FX ELECTROSURGICAL UNIT (ESU). ACCORDING TO THE NURSING CLINICAL LEADER, THE SURGEON INVOLVED WITH THIS EVENT TYPICALLY USE 45 (COAG), 45 (CUT), AND 25 (BIPOLAR) SETTINGS. SHE DID NOT KNOW HOW LONG THE INSTRUMENT AND ACCESSORY WERE IN USE BEFORE THE ARCING EVENT OCCURRED. ON (B)(4) 2013, ISI ALSO CONTACTED THE CSR FOR THE SITE, WHO WAS PRESENT DURING THE EVENT, AND OBTAINED ADDITIONAL INFORMATION. HE VERIFIED THAT THE MCS TIP COVER ACCESSORY WAS MELTED ON THE SIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF ALLEGED THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY, INSTALLED ON THE MCS INSTRUMENT, BURNED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. 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
    74577 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC.

    Patients

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