BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 19973705 · Received August 13, 2024

    Report

    Report Number
    2955842-2024-18056
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    December 20, 2023
    Report Date
    July 17, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTICLE AUTHOR STATED THAT THE DESCRIBED LYMPHOCELES IN THE ARTICLE WERE NOT RELATED TO THE DA VINCI SYSTEMS, BUT RELATED TO THE PROCEDURES PERFORMED.

    Additional Manufacturer Narrative · 0

    THERE IS INSUFFICIENT INFORMATION ON THE PROCEDURE DATE AND THUS A SYSTEM LOG WAS NOT AVAILABLE TO BE PERFORMED. THERE IS ALSO INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT THE PROCEDURE HAD COMPLICATION, AS BOTH DA VINCI X/XI AND SI SYSTEM WERE MENTIONED IN THE ARTICLE WITHOUT THE SPECIFIC PRODUCT INFORMATION. THEREFORE, THE PRODUCT IS REPORTED AS A N/A (FOR REGULATORY USE). SOURCE: DE JONG A, BAETEN IGT, JANSEN A, HOOGENDAM JP, JÜRGENLIEMK-SCHULZ IM, ZWEEMER RP, GERESTEIN CG. SYMPTOMATIC LYMPHOCELE AFTER ROBOT-ASSISTED PELVIC LYMPHADENECTOMY AS PART OF THE PRIMARY SURGICAL TREATMENT FOR CERVICAL AND ENDOMETRIAL CANCER: A RETROSPECTIVE COHORT STUDY. J MINIM INVASIVE GYNECOL. 2024 MAR;31(3):243-249.E2. DOI: 10.1016/J.JMIG.2023.12.010. EPUB 2024 JAN 1. PMID: 38171478.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    DURING A REVIEW OF A CLINICAL LITERATURE ARTICLE THAT INVESTIGATED THE INCIDENCE AND RISK FACTORS OF SYMPTOMATIC LYMPHOCELE POST ROBOTIC-ASSISTED PELVIC LYMPH NODE DISSECTION (PLND), THE FOLLOWING EVENTS WERE MENTIONED. A TOTAL OF 387 PATIENTS THAT UNDERWENT ROBOTIC ASSISTED PLND WERE INCLUDED IN THE STUDY, THE INCIDENCE OF SYMPTOMATIC LYMPHOCELE WAS 9.6% (37 PATIENTS). 27 PATIENTS WITH CERVICAL CANCER AND 10 PATIENTS WITH ENDOMETRIAL CANCER. A SYMPTOMATIC LYMPHOCELE IS DEFINED AS A LYMPHOCELE VISIBLE ON IMAGING WITH THE PRESENCE OF SYMPTOMS CAUSED BY COMPRESSION OF ADJACENT STRUCTURES, PELVIC PAIN, INFECTION OR DEEP VEIN THROMBOSIS. ONE PATIENT DEVELOPED A DEEP VENOUS THROMBOSIS AS A RESULT OF A LYMPHOCELE, WITHOUT THE NEED OF INVASIVE INTERVENTION AND WAS CLASSIFIED AS GRADE 2. THERE WERE 36 PATIENTS CONSIDERED AS GRADE 3 SYMPTOMATIC LYMPHOCELE REQUIRED HOSPITALIZATION. THE MEDIAN LENGTH OF HOSPITALIZATION WAS 8 DAYS. AMONG THE 36 PATIENTS, 8 PATIENTS REQUIRED INTRAVENOUS ANTIBIOTICS, 28 PATIENTS REQUIRED DRAINAGE IN ADDITION TO ANTIBIOTICS. ONE OF THE PATIENTS HAD RECURRENT SYMPTOMATIC LYMPHOCELE AND REQUIRED ANTIBIOTICS TREATMENT REPEATEDLY AS THE LOCATION WAS HARD TO DRAIN. SMOKING, AGE, BODY MASS INDEX (BMI) AND HISTORY OF PRIOR ABDOMINAL SURGERY WERE IDENTIFIED AS RISK FACTORS IN EITHER THE COHORTS OR IN THE PATIENTS HAD CERVIX OR ENDOMETRIAL CANCER. THERE WAS NO MENTION OF ANY DEVICE MALFUNCTIONS OCCURRED DURING THE ROBOTIC ASSISTED SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895640 DA VINCI DA VINCI NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES