BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 24329497 · Received February 12, 2026

    Report

    Report Number
    2955842-2026-03997
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    May 31, 2025
    Report Date
    May 7, 2026
    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
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAME EVENT HAS BEEN SUBMITTED UNDER MFR #2955842-2026-04833.

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. CITATION: ZHAO, L., ET. AL. (2025). SURGICAL OUTCOMES OF ROBOTIC HYSTERECTOMY FOR LARGE UTERUS WEIGHING MORE THAN 1000G: A RETROSPECTIVE STUDY FROM A HIGH-VOLUME CENTER. JOURNAL OF ROBOTIC SURGERY, 19, 253. HTTPS://DOI.ORG/10.1007/S11701-025-02422-1. SECTION A2: PATIENT INFORMATION AGE: REFLECTS THE STUDY MEAN AGE OF THE PATIENTS. SECTION B7: THE PATIENT'S MEDICAL HISTORY IS UPDATED PER THE MAJORITY OF THE PATIENT'S CHARACTERISTICS. SECTION D: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS USED. SECTION E: SINCE THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY ISI, RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT.

    Additional Manufacturer Narrative · 0

    THIS RECORD WAS IDENTIFIED AS A DUPLICATE OF ANOTHER SUBMITTED MDR WITH MANUFACTURER REPORT NUMBER 2955842-2026-04833. NO ADDITIONAL INFORMATION WILL BE SUBMITTED UNDER THIS REPORT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    A REVIEW OF AN ARTICLE THAT INVESTIGATED THE IMPACT OF VARIOUS RISK FACTORS ON SURGICAL OUTCOMES AND TO IDENTIFY THE MOST EFFECTIVE SURGICAL APPROACH FOR PERFORMING ROBOTIC HYSTERECTOMY (RH) WAS PERFORMED. THE ARTICLE DESCRIBES A FEW NON-SPECIFIC INTRA-OPERATIVE COMPLICATIONS WITH MINIMAL DETAILS. A TOTAL OF 4 INCIDENTS OF ORGAN INJURIES WERE RECORDED. ONE PATIENT EXPERIENCED A BLADDER INJURY, AND THREE PATIENTS EXPERIENCED VAGINAL LACERATIONS, ALL OF WHICH REQUIRED INTRAOPERATIVE REPAIR WITHOUT SUBSEQUENT COMPLICATIONS. ADDITIONALLY, 6 CASES NECESSITATED INTRAOPERATIVE BLOOD TRANSFUSIONS. POST-OPERATIVELY, ONE PATIENT SUFFERED A CUFF INFECTION AND URINARY TRACT INFECTION REQUIRING ANTIBIOTIC THERAPY, AND ANOTHER PATIENT EXPERIENCED CUFF DEHISCENCE AND BLEEDING LEADING TO READMISSION AND RESOLUTION AFTER SECONDARY SUTURE, AND ONE PATIENT EXPERIENCED URINARY RETENTION REQUIRING CATHETERIZATION FOR 2 WEEKS. ELEVEN CASES REQUIRED POSTOPERATIVE BLOOD TRANSFUSIONS. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI MADE 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 H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283228 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-15 N/A 00886874110690

    Patients

    Seq Age Sex Outcome Treatment
    1