BEUDAMED
    FDA Adverse Event Death Summary report: N

    WECK VISTA

    MDR report key: 20903133 · Received December 11, 2024

    Report

    Report Number
    2955842-2024-23077
    Event Type
    Death
    Date Received
    December 11, 2024
    Date of Event
    November 4, 2024
    Report Date
    November 15, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K152663
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SYSTEM LOGS FOUND THAT NO RELEVANT ERRORS OCCURRED DURING THE PROCEDURE. LOG REVIEW OF THE TWO SUBSEQUENT PROCEDURES PERFORMED ON THE SYSTEM FOUND NO ERRORS OCCURRED. THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: 30 DEGREE ENDOSCOPE PLUS, 0 DEGREE ENDOSCOPE PLUS, TWO LARGE NEEDLE DRIVERS, MARYLAND BIPOLAR FORCEPS, PROGRASP FORCEPS, AND MONOPOLAR CURVED SCISSORS. A SITE HISTORY REVIEW FOUND NO COMPLAINTS WERE MADE FOR THE INSTRUMENTS USED DURING THIS PROCEDURE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE DEVICE(S) USED DURING THE PROCEDURE AND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS EVENT. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT IN THIS REPORT DIED FOLLOWING AN UNRECOGNIZED TROCAR INJURY TO THE BOWEL WHICH OCCURRED DURING A ROBOTIC PROSTATECTOMY. THIS INJURY WAS NOT DISCOVERED AT THE TIME OF THE INITIAL SURGERY AND THE PATIENT BECAME SEPTIC REQUIRING ADDITIONAL PROCEDURES. THEY ULTIMATELY DIED AS A RESULT OF THIS COMPLICATION. HOW THE INJURY OCCURRED IS NOT REPORTED. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY (WITHOUT LYMPHADENECTOMY), A SMALL BOWEL INJURY OCCURRED WHILE PORTS WERE BEING PLACED DUE TO BAD ADHESIONS. THE INJURY OCCURRED WHEN PLACING A DA VINCI 8MM, SHORT, BLADELESS OBTURATOR. THE INJURY WENT UNDIAGNOSED AND RESULTED IN POST-OPERATIVE COMPLICATIONS. ON POST-OPERATIVE DAYS 1 AND 2, FOLLOWING THE ONSET OF SEPSIS, THE PATIENT UNDERWENT TWO ADDITIONAL, NON-ROBOTIC SURGERIES TO RESOLVE THE BOWEL INJURY; IT IS UNKNOWN WHAT REPAIRS WERE PERFORMED DURING THESE PROCEDURES. THE PATIENT EXPIRED ON POST-OPERATIVE DAY 3. IT WAS REPORTED THAT THE DA VINCI SYSTEM AND INSTRUMENTS USED DURING THE PROCEDURE WORKED FINE WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597726 WECK VISTA BLADELESS OBTURATOR GCJ INTUITIVE SURGICAL, INC 470359 UNKNOWN

    Patients

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