BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 19652284 · Received July 1, 2024

    Report

    Report Number
    2955842-2024-16277
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION THAT A DA VINCI DEVICE DIRECTLY CAUSED THE BLEEDING OR THE CARDIOGENIC SHOCK. A REVIEW OF THE SYSTEM LOG REVEALED NO RELATED SYSTEM ERRORS OCCURRING DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL, INC. MEDICAL SAFETY OFFICER CONCLUDED THAT THE BOTH POST-OPERATIVE BLEEDING AND THE CARDIAC EVENT ARE NOT RELATED TO THE DEVICE BUT PROBABLY RELATED TO THE PROCEDURE. THE PATIENT HAD A BLEEDING EVENT FOLLOWING COLPOSACROPEXY WITH MESH. THE BLEEDING OCCURRED WITH THE FIRST 24 HOURS AND REQUIRED AN EMERGENT RE-EXPLORATION. THE LOCATION OF THE BLEED WAS ON THE ANTERIOR LONGITUDINAL LIGAMENT WHICH OVERLAYS THE SPINE AND SACRUM. ANATOMICALLY, THIS IS TYPICALLY A REGION WITH A RICH PLEXUS OF VEINS. MESH HAD BEEN FIXED INTO THIS AREA AS WELL. THE BLEEDING WHICH OCCURRED HAS BEEN KNOWN TO OCCUR IN THIS TYPE OF SURGERY OR OTHER SIMILAR PELVIC PROCEDURES WHILE WORKING IN THIS AREA. THEREFORE, THIS EVENT MAY BE PROCEDURE RELATED. EROSION INTO VESSELS OR OTHER STRUCTURES FROM THE USE OF MESH IS POSSIBLE BUT THAT IS MORE COMMONLY A LONG-TERM COMPLICATION AND NOT LESS LIKELY TO BE THE CAUSE OF THIS BLEED SINCE IT OCCURRED WITHIN THE FIRST 24 HOURS. FOLLOWING THE RE-OPERATION AND RESOLUTION OF THE BLEEDING, THE PATIENT SUFFERED A CARDIAC EVENT WITHIN 24 HOURS OF THE BLEEDING EVENT. THE PATIENT WAS DISCOVERED TO HAVE SEVERE CORONARY 3 VESSEL DISEASE WHICH WAS NOT KNOWN PRE-OPERATIVELY. A CORONARY ANGIOGRAPHY WAS PERFORMED AND TWO DRUG ELUTING STENTS WERE IMPLANTED. THE CARDIAC EVENT WHICH FOLLOWED THIS BLEEDING EVENT WAS MOST LIKELY A CONSEQUENCE OF THE PRE-EXISTING 3 VESSEL CORONARY DISEASE. HOWEVER, THE BLEEDING, AND THEREFORE THE PROCEDURE THAT LED TO THE BLEEDING, CAN NOT BE EXCLUDED AS A POSSIBLE A CONTRIBUTING FACTOR AND REMAINS A CONFOUNDING VARIABLE. NO ALLEGATION HAS BEEN MADE ABOUT ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS THAT MAY HAVE LED TO THIS BLEED OR THE SUBSEQUENT CARDIAC EVENT.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED TO REFLECT THE PREVIOUSLY REPORTED EVENT DETAILS, INCLUDING THE PATIENT'S HEMOGLOBIN THAT HAD DROPPED POST-PROCEDURALLY, AND THE PATIENT'S DIAGNOSIS OF NON- ST ELEVATION MYOCARDIAL INFARCTION. ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS B6 AND H10.

    Description of Event or Problem · 0

    A PATIENT WHO WAS ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI-ASSISTED NERVE SPARING COLPOSACROPEXY WITH GYNEMESH-PS INTERPOSITION WITH POSTERIOR COLPORRHAPHY. THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING THAT REQUIRED REOPERATION AND A CARDIAC EVENT THAT ELUTING STENTS WERE PLACED. THE PROCEDURE WAS COMPLETED WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS NOR DEVICE MALFUNCTIONS REPORTED. INTRA-OPERATIVE BLEEDING WAS REPORTED AS A FEW MILLILITERS, WHICH WAS WITHIN EXPECTED BLEEDING AMOUNT. THE NEXT DAY, THE PATIENT WAS REPORTED AS UNSTABLE WITH HER HEMOGLOBIN DROPPED AND AN EMERGENT LAPAROSCOPIC SURGERY WAS PERFORMED. A HEMORRHAGE AROUND THE FIXATION SITE OF THE COLPOSACROPEXY MESH ON THE LONGITUDINAL ANTERIOR LIGAMENT WAS OBSERVED. THREE UNITS OF ERYTHROCYTE CONCENTRATES WERE REQUIRED. HEMOSTASIS BY ELECTROCOAGULATION AND COMPRESSION AROUND THE ANTERIOR LONGITUDINAL LIGAMENT AND SUBSEQUENT CLOSURE OF THE PERITONEUM WITH A VLOC SUTURE WAS PERFORMED. ON THE SAME DAY, THE PATIENT WENT INTO A CARDIOGENIC SHOCK AND EXPERIENCED A NON- ST ELEVATION MYOCARDIAL INFARCTION. A SEVERE CORONARY 3 VESSEL DISEASE WAS DIAGNOSED WHERE TWO DRUG ELUTING STENTS WERE PLACED. THE COMPLICATIONS WERE ASSESSED AS SEVERE AND CLAVIEN-DINDO GRADE IVA BY THE STUDY INVESTIGATOR. THE STUDY INVESTIGATOR DID NOT THINK THE CARDIOGENIC SHOCK WAS RELATED TO THE POST-OPERATIVE BLEEDING BUT RATHER THE PATIENT'S UNDIAGNOSED PRE-EXISTING CONDITION.

    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
    683754 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-42 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Life Threatening| R| H DA VINCI INSTRUMENTS AND ACCESSORIES.