BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI X/XI

    MDR report key: 18708105 · Received February 14, 2024

    Report

    Report Number
    2955842-2024-11378
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 23, 2024
    Report Date
    January 29, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE MCS TIP ACCESSORY WAS NOT RETURNED WITH THE MCS INSTRUMENT. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ISI RECEIVED THE MCS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE MCS INSTRUMENT WAS ANALYZED AND FOUND A SCRATCHED MAIN TUBE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE SCRATCH MARKS WERE 0.124¿ - 0.548¿ IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. ADDITIONAL OBSERVATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE DRIED RESIDUE AROUND THE CLAMPING PULLEY CABLE GROOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE PROTECTIVE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER INDICATED THEY HAVE NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136300 DA VINCI X/XI MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 400180-14 N/A

    Patients

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