BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20668449 · Received November 12, 2024

    Report

    Report Number
    2955842-2024-21797
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    April 20, 2024
    Report Date
    October 17, 2024
    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
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATES AND DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OR INDICATION OF ANY DA VINCI PRODUCT ISSUES NOTED WITHIN THE ARTICLE. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. CITATION: ZHAO, S., LI, R., ZHOU, J. ET AL. COMPARISON OF ROBOTIC VERSUS LAPAROSCOPIC SURGERY FOR VISCERAL OBESITY IN MID¿LOW RECTAL CANCER: A PROPENSITY-MATCHED ANALYSIS. J ROBOTIC SURG 18, 178 (2024). HTTPS://DOI.ORG/10.1007/S11701-024-01945-3. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THIS PATIENT. THE MEAN/MEDIAN AGE OF THE WHOLE ROBOTIC GROUP IS NOT PROVIDED, MAJORITY OF THE PATIENTS (B)(4) WERE MALES. SECTION B3: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED DATE HAS BEEN USED.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY THAT COMPARED THE SURGICAL RESULTS OF ROBOTIC VERSUS LAPAROSCOPIC RECTAL SURGERY FOR TREATING BOTH VISCERAL OBESITY (VO) AND MID¿LOW RECTAL CANCER. THE STUDY INCLUDED 242 PATIENTS THAT UNDERWENT LAPAROSCOPIC OR ROBOTIC ANTERIOR RECTAL EXCISION IN ONE SINGLE INSTITUTION. OF THE 242 CASES, 121 PATIENTS WERE ASSIGNED TO THE ROBOTIC SURGERY (RS) GROUP AND ANOTHER 121 PATIENTS TO THE LAPAROSCOPIC SURGERY (LS) GROUP. IN THE RS GROUP, TWO PATIENTS WERE CONVERTED TO LAPAROTOMY DUE TO BLEEDING, AND ONE PATIENT WAS CONVERTED TO LAPAROTOMY DUE TO URINARY TRACT INJURY. TWENTY-TWO PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS, WHICH INCLUDED THE FOLLOWING: 2 CASES OF UNSPECIFIED BLEEDING, 6 CASES OF ANASTOMOTIC LEAK, 3 CASES OF ILEUS, 1 CASE OF PELVIC ABSCESS, 1 CASE OF URETERIC INJURY, 1 CASE OF URINARY RETENTION, AND 4 CASES OF PULMONARY INFECTION. AMONG THE 22 POST-OPERATIVE COMPLICATIONS, TWO OF THE COMPLICATIONS WERE CLASSIFIED AS GREATER THAN CLAVIEN-DINDO GRADE III. THERE WAS NO MENTION OF THE MEDICAL INTERVENTION THAT WERE PERFORMED FOR THE COMPLICATIONS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541165 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.