BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 20563832 · Received October 29, 2024

    Report

    Report Number
    2955842-2024-21273
    Event Type
    Death
    Date Received
    October 29, 2024
    Date of Event
    October 4, 2024
    Report Date
    October 4, 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
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5 ADDITIONAL INFORMATION: THE HOSPITAL SITE CLINICAL SALES ASSOCIATE (CSA) SPOKE TO THE SURGEON ON (B)(6) 2024. THE SURGEON STATED THAT THIS EVENT HAD NOTHING TO DO WITH THE DA VINCI DEVICES AND THERE WAS NO OTHER INFORMATION TO PROVIDE ON THIS EVENT. THE CSA CLARIFIED THAT CPR WAS ADMINISTERED, NOT CCR.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SYSTEM LOGS FOUND THAT NO RELEVANT ERRORS OCCURRED DURING THE PROCEDURE. LOG REVIEW OF THE 5 SUBSEQUENT PROCEDURES PERFORMED ON THE SYSTEM FOUND NO ERRORS OCCURRED THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: 30 DEGREE ENDOSCOPE PLUS, FENESTRATED BIPOLAR FORCEPS, MONOPOLAR CURVED SCISSORS, MEGA SUTURECUT NEEDLE DRIVER. 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 MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT IN THIS REPORT DIED SHORTLY AFTER AN INGUINAL HERNIA REPAIR. THE PATIENT HAD CHEST PAINS PRIOR TO SURGERY BUT THE PROCEDURE WAS CARRIED OUT ANYWAY. NO ISSUES OR OTHER COMPLICATIONS OCCURRED DURING THE PROCEDURE. THE CAUSE OF DEATH IS NOT GIVEN BUT THE PREOPERATIVE CHEST PAIN IS CONCERNING FOR A CARDIAC EVENT. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, NO INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ELECTIVE DA VINCI-ASSISTED INGUINAL HERNIA REPAIR, THE PATIENT ¿WOULD NOT WAKE UP FROM ANESTHESIA¿ AND PASSED AWAY. THE PATIENT HAD REPORTEDLY EXPERIENCED CHEST PAIN PRIOR TO THE PROCEDURE. THE CAUSE OF THE CHEST PAIN AND THE PATIENT¿S MEDICAL HISTORY WERE NOT PROVIDED. THE SITE ROBOTICS COORDINATOR INFORMED THE INTUITIVE CLINICAL SALES ASSOCIATE THAT THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE DA VINCI ROBOT WAS UNDOCKED. THE HOSPITAL OR STAFF ATTEMPTED TO WAKE THE PATIENT BUT WERE UNSUCCESSFUL. CARDIOCEREBRAL RESUSCITATION (CCR) WAS ADMINISTERED AND AN INTERVENTION TEAM WAS CALLED TO ASSIST; HOWEVER, THE PATIENT EXPIRED. THE ROBOTICS COORDINATOR REPORTED THAT THE EVENT HAD NOTHING TO DO WITH THE DA VINCI PRODUCTS. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020294 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

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