BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 14310290 · Received May 6, 2022

    Report

    Report Number
    2955842-2022-11432
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 5, 2022
    Report Date
    April 5, 2022
    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
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOGS FOR THIS PROCEDURE HAS BEEN PERFORMED AND THE FOLLOWING WAS OBSERVED: ERROR 25920 WAS OBSERVED INDICATING THE ERBE ENERGY ACTIVATION WAS HALTED BY AN INSTRUMENT OR INSTRUMENT CABLE CONNECTED TO THE LOWER BIPOLAR PORT ON THE ERBE GENERATOR WHILE THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS SEALING. ADDITIONALLY, ALL MULTI-USE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES WITH THE EXCEPTION OF THE SINGLE-USE INSTRUMENTS AND THE FOLLOWING INSTRUMENTS: MEGA NEEDLE DRIVER (PART #470194-05 / LOT #K1021004-0226 / USES REMAINING: 7). A SITE COMPLAINT HISTORY REVIEW AS OF 02-MAY-2022 SHOWS THAT NO ADDITIONAL COMPLAINTS HAVE BEEN CREATED FOR THIS EVENT NOR ANY OF THE INSTRUMENTS USED DURING THIS PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE ILIAC ARTERY WAS DAMAGED. AS A RESULT, THE SURGEON PLACED AN UNSPECIFIED CLAMP ON THE VESSEL. FURTHERMORE, THE PATIENT RECEIVED UNSPECIFIED MEDICAL INTERVENTION FROM A VASCULAR SURGEON. WHILE THE CONSOLE SURGEON INDICATED THAT THE EVENT WAS "NOT PRODUCT RELATED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE ILIAC ARTERY WAS DAMAGED. THE SURGEON PLACED AN UNSPECIFIED CLAMP ON THE ARTERY AND COMPLETED THE PROCEDURE ROBOTICALLY. HOWEVER, IT WAS NOTED THAT THE PATIENT WAS RUSHED TO VASCULAR TO SAVE THE LEG. AN INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), WAS CONTACTED AND ADDITIONAL INFORMATION WAS OBTAINED ON THIS COMPLAINT: THE CUSTOMER MADE NO ALLEGATIONS AGAINST ANY ISI PRODUCTS REGARDING THIS EVENT. THE CSR WAS NOT PRESENT AND WAS INFORMED OF THIS EVENT BY MULTIPLE STAFF MEMBERS. THE CSR DOES NOT KNOW HOW THE ARTERY WAS DAMAGED. THE PATIENT WAS TREATED BY A VASCULAR SURGEON AS A RESULT OF THIS EVENT AND REPORTEDLY DID WELL POST-OPERATIVELY. ISI CONTACTED THE SURGEON WHO PERFORMED THE DA VINCI-ASSISTED SURGICAL PROCEDURE AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED REGARDING THE REPORTED EVENT: THE SURGEON INDICATED THE EVENT WAS "NOT PRODUCT-RELATED." THE SURGEON DID NOT PROVIDE ANY FURTHER CLINICAL INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281194 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-36 N/A 00886874115404

    Patients

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