BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19918506 · Received August 6, 2024

    Report

    Report Number
    2955842-2024-17530
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    CORRECT DATA CAN BE FOUND IN FIELDS E3 AND G2.

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO FIELD H10 FOR THE UF/IMPORTER REPORT THAT WAS RECEIVED AND NOTED IN THE B5 OF THE INITIAL MDR, BUT WAS NOT ADDED TO FIELD H10 AT THE TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA REPAIR PROCEDURE, THE CASE WAS ABORTED DUE TO THE PATIENT'S RAPID DECLINE IN STATUS. THE PATIENT BECAME HYPOTENSIVE AND OXYGEN SATURATION STARTED TO DECLINE. ANESTHESIA PERFORMED AN INTRAOPERATIVE BRONCHOSCOPY, WHERE A MUCUS PLUG WAS REMOVED. THE PROCEDURE CONTINUED. HOWEVER, THE PATIENT'S OXYGEN SATURATION STARTED TO DECLINE AGAIN AND THE PROCEDURE WAS THEN ABORTED WHILE A PORTION OF THE HIATAL HERNIA CLOSURE WAS COMPLETED. A CHEST TUBE WAS PLACED INTRAOPERATIVELY. THE PATIENT WAS THEN HOSPITALIZED. POSTOPERATIVE DAY TWO THE CHEST TUBE WAS REMOVED, A CHEST X-RAY SHOWED NO SIGNS OF A PNEUMOTHORAX, THE PATIENT WAS THEN DISCHARGED FROM THE HOSPITAL WITH NO FURTHER REPORTS OF COMPLICATIONS. ON 10-JUL-2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA MEDWATCH REPORT WITH UF/IMPORTER REPORT #(B)(4) STATING: "ROBOTIC DA VINCI MONOPOLAR SCISSORS ARE DULL. TAKEN OFF FIELD AND REPLACED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ROBOTIC ASSISTED LAPAROSCOPIC RECURRENT HIATAL HERNIA REPAIR- ABORTED. INSERTION OF RIGHT CHEST TUBE." IT WAS REPORTED THAT THE BLADES OF A MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENTS WERE DULL. THE MCS INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP MCS INSTRUMENT. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT DUE TO THE MCS INSTRUMENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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
    1703395 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES