BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 15654050 · Received October 21, 2022

    Report

    Report Number
    2955842-2022-14751
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    September 23, 2022
    Report Date
    September 23, 2022
    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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE REPORTED INJURY CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW FOR SYSTEM LOGS AT THE SITE WAS ATTEMPTED AND NO LOGS ARE AVAILABLE FOR THE EVENT SINCE THE SYSTEM WAS NEVER USED. THE INSTRUCTIONS FOR USE (IFU) FOR THE DA VINCI XI SYSTEMS CONTAINS THE FOLLOWING CAUTIONS TO MINIMIZE THE RISKS ASSOCIATED WITH PORT PLACEMENT. APPROPRIATE PATIENT POSITIONING TO SHIFT ORGANS AWAY FROM THE PORT PLACEMENT SITE. AN ADEQUATE LEVEL OF INSUFFLATION. OBTURATOR TIP IS POINTING AWAY FROM MAJOR VESSELS, ORGANS, AND OTHER ANATOMIC STRUCTURES. WHEN POSSIBLE, VISUALIZATION OF THE ENTIRE INSERTION OF THE CANNULA USING THE ENDOSCOPE IS PREFERRED. UTILIZE CONTINUOUS, CONTROLLED PRESSURE WITH A DELIBERATE ROTATING MOTION WHEN PLACING THE CANNULA AND OBTURATOR. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AT THE START OF A DA VINCI-ASSISTED LYSIS OF ADHESIONS PROCEDURE AND DURING INITIAL PORT PLACEMENT, AN UNSPECIFIED VESSEL/TISSUE WAS INJURED. AS A RESULT, THE PATIENT EXPERIENCED BLEEDING AND THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY. THE CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: B7, G3, G6, H2, H3, H6, AND H10. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON: HE STATED THAT THE INITIAL ENTRY WAS WITH AN INTUITIVE SURGICAL, INC. (ISI) TROCAR UNDER DIRECT VISUALIZATION. HE USED THE VARESS NEEDLE TECHNIQUE. AT THAT TIME, THE PATIENT EXPERIENCED A LOT OF BLEEDING. AS A RESULT, THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE. THE SURGEON IDENTIFIED A MESENTERIC VESSEL THAT WAS BLEEDING. HE THEN SUTURED THE VESSEL AND COMPLETED THE PROCEDURE AS AN OPEN SURGICAL PROCEDURE. THE SURGEON STATED THERE WERE APPROXIMATELY 2.5 LITERS OF BLOOD LOSS. THE PATIENT¿S HEMOGLOBIN DROPPED TO SEVEN; HOWEVER, SHE WAS ASYMPTOMATIC. THERE WAS NO BLOOD TRANSFUSION RENDERED TO THE PATIENT. THE SURGEON STATED THE PATIENT HAD RECOVERED WELL WITH NO POST-OPERATIVE ISSUES. THE SURGEON NOTED THE PATIENT DID HAVE AN EXTENDED HOSPITALIZATION SECONDARY TO THE OPEN SURGICAL PROCEDURE. HE STATED THE TROCAR WOULD NOT BE RETURNED TO ISI FOR EVALUATION. THE SURGEON IS NOT SURE IF THE ISI TROCAR TIP IS SLIGHTLY SHARPER THAN LAPAROSCOPIC TROCARS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT THE START OF A DA VINCI-ASSISTED LYSIS OF ADHESIONS PROCEDURE, AN UNSPECIFIED VESSEL/TISSUE WAS INJURED WHILE THE SURGEON WAS PLACING A PORT. AS A RESULT, THE PATIENT EXPERIENCED BLEEDING AND THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY. THE BLOOD LOSS VOLUME IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: PER THE CSR, UNSPECIFIED ISI AND THIRD-PARTY PRODUCTS WERE USED WHEN THE EVENT OCCURRED. THE EVENT OCCURRED DURING INITIAL PORT ENTRY; HOWEVER, DA VINCI SYSTEM WAS NOT DOCKED YET AT THE TIME. IT IS UNKNOWN WHAT SPECIFIC TROCAR WAS USED DURING INITIAL PORT PLACEMENT AND IF THE TROCAR WAS INSERTED WITH DIRECT VISUALIZATION. FURTHERMORE, IT IS UNKNOWN WHAT SPECIFIC MEDICAL/SURGICAL INTERVENTION WAS RENDERED DUE TO THE VESSEL/TISSUE INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    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
    1647381 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.