BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18640232 · Received February 5, 2024

    Report

    Report Number
    2955842-2024-11038
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    January 6, 2024
    Report Date
    January 9, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POSTOPERATIVE COMPLICATION CANNOT BE DETERMINED. NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ASSOCIATED WITH THIS COMPLAINT, AND A FAILURE ANALYSIS (FA) INVESTIGATION WAS COMPLETED. FA DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. A VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM, WHERE IT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY, WITH FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT RELEASED ENERGY. NO ARCING OR THERMAL DAMAGE WAS OBSERVED. THE INSTRUMENT WAS FULLY FUNCTIONAL, AND NO PRODUCT ISSUE WAS IDENTIFIED. ISSUES RELATED TO INSTRUMENT ERRORS OR TO COMPLICATIONS USING THE INSTRUMENT REPORTED BY THE USER WITH NO UNDERLYING PRODUCT ISSUE MAY BE RELATED TO CUSTOMER-INDUCED PROBLEMS, INCLUDING MISUSE OF THE PRODUCT AND RECOGNITION ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DAY AFTER A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, A PORT SITE BURN WAS NOTED WHILE THE PATIENT'S DRESSINGS WERE CHANGED. THE PORT SITE IN QUESTION WAS THE SITE WHERE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS IN USE. THE SEVERITY OF THE BURN, ANY MEDICAL INTERVENTIONS REQUIRED, AND THE PATIENT'S STATUS ARE CURRENTLY UNKNOWN. IT IS ALSO UNKNOWN IF THE MCS INSTRUMENT WAS INVOLVED IN THE REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1622530 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K15230108 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male DA VINCI INSTRUMENTS AND ACCESSORIES