BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 16728942 · Received April 12, 2023

    Report

    Report Number
    2955842-2023-11924
    Event Type
    Death
    Date Received
    April 12, 2023
    Date of Event
    February 28, 2023
    Report Date
    March 20, 2023
    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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POSTOPERATIVE COMPLICATION CANNOT BE DETERMINED. THE SURGEON REPORTED NO DEVICE ISSUES OR OTHER COMPLICATIONS DURING THE PROCEDURE AND SUSPECTS A POSSIBLE POSTOPERATIVE COMPLICATION RELATED TO PATIENT COMORBIDITIES. AN AUTOPSY IS REPORTED TO BE PENDING. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED THAT FOUND THERE WERE NO RELATED SYSTEM ERRORS THAT OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUMENT LOG FOUND THAT ALL REUSABLE INSTRUMENTS USED DURING THE PROCEDURE WERE USED FOR SUBSEQUENT PROCEDURES OR HAD ZERO USES REMAINING AFTER THE PROCEDURE. A REVIEW OF THE EVENT WAS COMPLETED BY AN ISI MEDICAL OFFICER WHO CONCLUDED THAT ACCORDING TO THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, THIS PATIENT EXPIRED AT HOME 5 DAYS FOLLOWING A LEFT UPPER LOBECTOMY WHICH WAS REPORTED AS AN UNEVENTFUL PROCEDURE WITH NO DEVICE ISSUES DURING THE CASE. THIS PATIENT HAD SIGNIFICANT KNOWN COMORBIDITIES. AN AUTOPSY REPORT WAS NOT PROVIDED, AND THE CAUSE OF DEATH IS UNKNOWN. INSUFFICIENT INFORMATION EXISTS TO ASCERTAIN IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS CATASTROPHIC EVENT. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNEVENTFUL DA VINCI-ASSISTED LEFT UPPER LOBE PULMONARY LOBECTOMY PROCEDURE. THE PATIENT WAS DISCHARGED HOME AND EXPIRED WHILE SLEEPING ON POSTOPERATIVE DAY 5. ALTHOUGH THE SURGEON REPORTED THAT THERE WERE NO DEVICE ISSUES EXPERIENCED DURING THE PROCEDURE, THIS EVENT IS BEING CONSERVATIVELY REPORTED AS THE CAUSE OF DEATH IS UNKNOWN PENDING AUTOPSY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBE PULMONARY LOBECTOMY PROCEDURE ON (B)(6) 2023. THE SURGEON REPORTED VIA THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE THAT THERE WERE NO DEVICE ISSUES OR COMPLICATIONS EXPERIENCED DURING THE PROCEDURE AND THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2023 THE PATIENT PASSED AWAY AT HOME IN THEIR SLEEP. THE SURGEON REPORTED THAT HE DOES NOT KNOW THE CAUSE OF DEATH AND DOES NOT BELIEVE THAT THE DAVINCI SYSTEM HAD ANYTHING TO DO WITH THE PATIENT DEATH. HE STATED THAT HE THINKS THE PATIENT MAY HAVE HAD A POSTOPERATIVE COMPLICATION SUCH AS A HEART ATTACK OR PULMONARY EMBOLUS GIVEN COMORBID CONDITIONS OF CANCER, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DIABETES, AND SLEEP APNEA THAT MIGHT HAVE CAUSED OR CONTRIBUTED TO THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087137 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-38 N/A 00886874110720

    Patients

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