BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI

    MDR report key: 9923319 · Received April 3, 2020

    Report

    Report Number
    2955842-2020-10273
    Event Type
    Death
    Date Received
    April 3, 2020
    Report Date
    March 5, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G4, G7, H2, AND H10/11. CORRECTED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELD: H10/11. H10/11 SHOULD HAVE NOTED THE FOLLOWING ON THE INITIAL MDR SUBMISSION: SECTIONS G5 (510K #) AND H4 (DEVICE MANUFACTURE DATE) ARE NOT AVAILABLE DUE TO INSUFFICIENT PRODUCT INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE AIR EMBOLISM AND PATIENT DEATH ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE FOLLOWING INFORMATION IS ALSO UNKNOWN: THE TYPE OF DA VINCI-ASSISTED UROLOGICAL PROCEDURE THAT WAS PERFORMED, THE DATE THE SURGICAL PROCEDURE WAS PERFORMED, WHEN THE AIR EMBOLISM WAS IDENTIFIED, WHAT MEDICAL INTERVENTION WAS ADMINISTERED DUE TO THE AIR EMBOLISM, AND WHAT DATE THE PATIENT EXPIRED. A REVIEW OF THE SITE¿S SYSTEM LOGS RELATED TO THE DA VINCI-ASSISTED SURGICAL PROCEDURE IN QUESTION CANNOT BE PERFORMED SINCE THE EVENT DATE IS UNKNOWN. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT UNDERWENT AN UNSPECIFIED DA VINCI-ASSISTED UROLOGICAL PROCEDURE AND ALLEGEDLY EXPIRED FROM AN AIR EMBOLISM RELATED TO THE USE OF AN AIR SEAL DEVICE (A 3RD-PARTY MANUFACTURER DEVICE). THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM OCCURRED. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN OR UNAVAILABLE. THE EXPIRATION DATE IS NOT APPLICABLE. FIELD IMPLANT DATE IS NOT APPLICABLE BECAUSE THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PROFESSOR OF RESPIRATORY SURGERY THAT A PATIENT UNDERWENT AN UNSPECIFIED UROLOGICAL DA VINCI-ASSISTED SURGICAL PROCEDURE ON AN UNSPECIFIED DATE. THE PROFESSOR INDICATED THAT THE PATIENT DIED FROM AN AIR EMBOLISM AS A RESULT OF USING AN AIR SEAL (A 3RD PARTY MANUFACTURER DEVICE) BY INCREASING THE PRESSURE TO INCREASE THE HEMOSTATIC EFFECT. ON 12-MAR-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) REPORTEDLY HEARD THAT THE RESPIRATORY SURGEON HAD CONDUCTED THE DA VINCI-ASSISTED UROLOGICAL PROCEDURE. THE SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, IT IS UNKNOWN IF THE VIDEO IS AVAILABLE FOR ISI TO REVIEW. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. NO FURTHER CLINICAL OR PATIENT INFORMATION WAS PROVIDED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386447 DA VINCI PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L DA VINCI INSTRUMENTS AND ACCESSORIES