BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 18380418 · Received December 21, 2023

    Report

    Report Number
    2955842-2023-21389
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    November 24, 2023
    Report Date
    November 26, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) TIP ACCESSORY. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SP MCS INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA WAS NOT ABLE TO CONFIRM AND REPRODUCE THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT HAD AN IN-HOUSE MCS TIP ACCESSORY INSTALLED AND THE INSTRUMENT DID NOT HAVE ANY ERROR WHEN INSTALLED ON THE SYSTEM. THE INSTRUMENT WAS ADVANCED INTO THE CANNULA AND WAS ABLE TO BE MOVED WITHOUT ISSUES NOTICED. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED. ADDITIONAL OBSERVATION(S) NOT RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE AN INSTRUMENT TUBE ADAPTER BROKEN. THERE WAS NO MISSING PIECE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE, THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) TIP ACCESSORY FELL OFF FROM THE SP MCS INSTRUMENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER ATTEMPTED TO REMOVE AND INSERTED ANOTHER SP MCS TIP BUT COULD NOT INSTALL IT PROPERLY. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SP MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND THE SP MCS TIP ACCESSORY WERE INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. DURING THE PROCEDURE, THE ACCESSORY FELL INTO THE PATIENT WHILE DISSECTING THE TISSUE. THE CUSTOMER RETRIEVED THE ACCESSORY DURING SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. POST-OPERATIVE TESTS WERE NOT PERFORMED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS AND THE ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING USE. THE CUSTOMER INDICATED THAT NO DAMAGE, TEARS OR HOLE FOUND ON THE ACCESSORY, INSTRUMENT, OR CANNULA AFTER THE EVENT OCCURRED. THERE WAS NO DIFFICULTY IN REMOVING THE INSTRUMENT AND ACCESSORY AND THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE ACCESSORY WAS ALREADY DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306199 NONE MONOPOLAR CURVED SCISSORS (MCS) TIP NAY INTUITIVE SURGICAL, INC 430035 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DA VINCI INSTRUMENTS AND ACCESSORIES.