BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19974097 · Received August 13, 2024

    Report

    Report Number
    2955842-2024-18055
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 17, 2024
    Report Date
    July 17, 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
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. 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, ONLY DA VINCI XI SYSTEM WAS MENTIONED IN THE ARTICLE WITHOUT THE SPECIFIC PRODUCT INFORMATION. THEREFORE, THE PRODUCT IS REPORTED AS A GENERAL DA VINCI XI SYSTEM. SOURCE: PINI R, MONGELLI F, IAQUINANDI F, GAFFURI P, PREVISDOMINI M, CIANFARANI A, LA REGINA D. SWITCHING FROM ROBOTIC-ASSISTED EXTENDED TRANSABDOMINAL PREPERITONEAL (ETAPP) TO TOTALLY EXTRAPERITONEAL (ETEP) HERNIA REPAIR FOR UMBILICAL AND EPIGASTRIC HERNIAS. SCI REP. 2024 JAN 20;14(1):1800. DOI: 10.1038/S41598-024-52165-6. PMID: 38245577; PMCID: PMC10799892.

    Description of Event or Problem · 0

    DURING A REVIEW OF A CLINICAL ARTICLE THAT ASSESSED THE SAFETY AND EFFECTIVENESS OF THE ROBOTIC-ASSISTED EXTENDED TOTALLY EXTRAPERITONEAL (ETEP) REPAIR WITH TRANSABDOMINAL PREPERITONEAL (ETAPP) REPAIR FOR UMBILICAL AND EPIGASTRIC HERNIAS, THE FOLLOWING POST-OPERATIVE COMPLICATIONS WERE MENTIONED. 53 PATIENTS WERE INCLUDED IN THE STUDY AND NO INTRA-OPERATIVE COMPLICATIONS OCCURRED ACCORDING TO THE ARTICLE. POST-OPERATIVELY, TWO COMPLICATIONS OCCURRED, BOTH IN THE ETEP GROUP. ONE PATIENT HAD A POST-OPERATIVE BLEEDING THAT REQUIRED A SURGICAL REVISION WITHOUT FURTHER COMPLICATIONS. ONE PATIENT HAD A SEROMA IN THE HERNIA SITE AND REQUIRED A PERCUTANEOUS ASPIRATION AND WAS CONFIRMED RESOLVED AFTER TWO MONTHS. BOTH COMPLICATIONS WERE ASSESSED AS CLAVIEN-DINDO GRADE III. THERE WAS NO MENTION OF ANY DEVICE MALFUNCTIONS THAT OCCURRED DURING THE ROBOTIC-ASSISTED SURGERIES. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163909 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES