BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

    MDR report key: 9840570 · Received March 17, 2020

    Report

    Report Number
    2955842-2020-10193
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    February 17, 2020
    Report Date
    February 17, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE MCS INSTRUMENT NOR THE ASSOCIATED TIP COVER ACCESSORY HAS BEEN RETURNED TO ISI FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE MCS INSTRUMENT OR THE MCS TIP COVER ACCESSORY ARE RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED HYSTERECTOMY, IT WAS ALLEGED THAT THE MCS INSTRUMENT ARCED AND BLACKENED THE TISSUE THE SURGEON WAS WORKING ON. THE SEVERITY OF THE "BLACKENED TISSUE" AND IF ANY MEDICAL INTERVENTION WAS RENDERED IN UNKNOWN AT THIS TIME. MDR FIELD INFORMATION: FOLLOW-UP WAS ATTEMPTED, BUT THE INFORMATION FOR THE FOLLOWING FIELDS WAS EITHER UNKNOWN OR UNAVAILABLE. THE NON-APPLICABLE SECTIONS ARE LEFT BLANK, BECAUSE IT IS NOT APPLICABLE TO ISI PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ARCED AND BLACKENED THE TISSUE WHEY WERE WORKING WITH. THE SURGEON REPORTED TO THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) THAT THERE WAS NO PATIENT INJURY. THE TSE HAD THE CUSTOMER REMOVE THE INSTRUMENT FROM ROTATION AND RECOMMENDED THAT THE SITE RETURN THE MCS INSTRUMENT TO ISI FOR FURTHER ANALYSIS. THE PROCEDURE WAS COMPLETED.¿ INTUITIVE SURGICAL INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304778 ENDOSCOPIC ELECTROSURGICAL INSTRUMENT TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14

    Patients

    Seq Age Sex Outcome Treatment
    1 Other