BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 17923445 · Received October 12, 2023

    Report

    Report Number
    2955842-2023-19143
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    July 26, 2023
    Report Date
    September 14, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    ON 14-SEP-2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY MDR REPORT #MW5145135 STATING: PER REPORT THE SURGEON WAS PERFORMING A ROBOTIC ASSISTED LAPAROSCOPIC CHOLECYSTECTOMY AND THE DA VINCI XI LARGE CLIP APPLIER BROKE. ONE OF THE TIPS OF THE TEETH WERE MISSING SO WE CALL FOR AN X RAY AND THE RADIOLOGIST TOOK A LOOK AND DIDN'T SEE THE MISSING PART. 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
    2115443 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-09 N/A

    Patients

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