BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 16776650 · Received April 20, 2023

    Report

    Report Number
    2955842-2023-12082
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    March 28, 2023
    Report Date
    March 28, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110690
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THERE WAS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AND THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A SYSTEM LOG CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME AS THERE WAS INSUFFICIENT INFORMATION. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY ARTICLE, AND IT WAS MENTIONED THERE WERE 22 POST-OPERATIVE COMPLICATIONS IN 54 PATIENTS THAT UNDERWENT ROBOTIC NIPPLE SPARING MASTECTOMIES (NSM). ACCORDING TO THE LITERATURE AUTHOR, OF THE 22 POST-OPERATIVE COMPLICATIONS, 13 OF THEM WERE SIGNIFICANT.

    Description of Event or Problem · 0

    ON 28-MAR-2023, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY ARTICLE TITLED, ¿ROBOTIC VERSUS CONVENTIONAL NIPPLE SPARING MASTECTOMY AND IMMEDIATE GEL IMPLANT BREAST RECONSTRUCTION IN THE MANAGEMENT OF BREAST CANCER- A CASE CONTROL COMPARISON STUDY WITH ANALYSIS OF CLINICAL OUTCOME, MEDICAL COST, AND PATIENT-REPORTED COSMETIC RESULTS¿ (LAI, H.W., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMIES (NSM) WITH IMMEDIATE GEL IMPLANT BREAST RECONSTRUCTION FROM JULY 2011 TO SEPTEMBER 2019 WERE NOTED. A TOTAL OF 22 POST-OPERATIVE COMPLICATIONS WERE REPORTED IN 54 PATIENTS THAT UNDERWENT ROBOTIC NSM. THE POST-OPERATIVE COMPLICATIONS WERE AS FOLLOWS: 5 PATIENTS HAD DELAYED WOUND HEALING, 6 PATIENTS HAD TRANSIENT PARTIAL NIPPLE ISCHEMIA, 1 PATIENT HAD PARTIAL NIPPLE AREOLAR COMPLEX NECROSIS, 3 PATIENTS HAD SEROMA FORMATION THAT NEEDED ASPIRATION, 1 PATIENT HAD BLISTER FORMATION, 5 PATIENTS HAD SKIN FLAP SMALL PARTIAL ISCHEMIA NECROSIS, 1 PATIENT HAD HEMATOMA FORMATION. OF THE 22 POST-OPERATIVE COMPLICATIONS, 13 OF THEM WERE SIGNIFICANT, ACCORDING TO THE LITERATURE AUTHOR. THE NON-SIGNIFICANT COMPLICATIONS WERE DEFINED AS TRANSIENT NIPPLE ISCHEMIA, WHICH RECOVERED AFTER CONSERVATIVE MANAGEMENT, AND SEROMA WHICH WAS RELIEVED AFTER REPEATED ASPIRATIONS. ALL THE PATIENTS HAD OPERABLE BREAST CANCER, AND THE DA-VINCI ASSISTED NIPPLE SPARING MASTECTOMIES WERE PERFORMED BY THE SAME SURGEON AT A SINGLE INSTITUTION. INTUITIVE SURGICAL, INC, (ISI) MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613411 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-10 N/A 00886874110690

    Patients

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