BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21009079 · Received December 23, 2024

    Report

    Report Number
    2955842-2024-23446
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    June 26, 2024
    Report Date
    December 2, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. CITATION: VIDHYA T., RAJIV P., AND SRIPATHI V. (2024) ANALYSIS OF OUTCOMES OF ROBOT-ASSISTED LAPAROSCOPIC PYELOPLASTY IN CHILDREN FROM A TERTIARY PEDIATRIC CENTER IN SOUTH INDIA. FRONT. PEDIATR. 12:1376644. DOI: 10.3389/FPED.2024.1376644. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. THE MEAN AGE OF THE PATIENTS WERE 4 YEARS, MAJORITY (77%) OF THE PATIENTS WERE MALES. FIELD 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 WAS REVIEWED THAT DESCRIBED A PROSPECTIVE OBSERVATIONAL STUDY TO ANALYZE THE OUTCOMES OF ROBOT-ASSISTED LAPAROSCOPIC PYELOPLASTY (RALP) IN CHILDREN WITH PELVI-URETERIC JUNCTION OBSTRUCTION (PUJO) OVER A 10-YEAR PERIOD. THE STUDY INCLUDED DATA FROM 2013 TO 2023 AND INVOLVED 185 CHILDREN WHO UNDERWENT RALP AT A SINGLE INSTITUTION. THE MEDIAN AGE WAS 4.9 YEARS. AMONG THE 185 PATIENTS THAT UNDERWENT RALP SURGERIES, TWO PATIENTS EXPERIENCED INTRA-OPERATIVE COMPLICATIONS. ONE PATIENT EXPERIENCED A PARTIAL RENAL VEIN TEAR WHICH WAS REPAIRED. THERE WAS ONE PROCEDURE WHERE A NEEDLE WAS LOST IN THE PATIENT'S ABDOMEN CAVITY BUT WAS RETRIEVED USING C-ARM GUIDANCE. TWO PATIENTS EXPERIENCED CLAVIEN-DINDO GRADE IIIB POST-OPERATIVE COMPLICATIONS, BOTH REQUIRING SURGICAL INTERVENTION. ONE CHILD EXPERIENCED OMENTAL HERNIATION AT THE UMBILICAL PORT SITE ON THE FIFTH POSTOPERATIVE DAY (POD). ANOTHER CHILD PRESENTED WITH A GROSSLY ENLARGED KIDNEY, ACCOMPANIED BY PAIN AND POOR ORAL INTAKE ON THE 10TH POD, ATTRIBUTED TO A BLOCKED DOUBLE-J STENT. AN EMERGENCY PERCUTANEOUS NEPHROSTOMY WAS PERFORMED, FOLLOWED BY REDO STENTING. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. THE DESIGNATED AUTHOR WAS CONTACTED, AND CONFIRMED THAT THERE WERE NO COMPLICATIONS RELATED TO THE DA VINCI SYSTEM OR INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512846 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.