BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SURGICAL SYSTEM

    MDR report key: 13654716 · Received March 2, 2022

    Report

    Report Number
    2955842-2022-10435
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    February 1, 2022
    Report Date
    February 1, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED OR IS UNKNOWN. IT IS UNCLEAR IF THE INTERVENTION FOR THE NECK ISSUE WAS REQUIRED BEFORE OR AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SITE HISTORY REVIEW WAS UNABLE TO BE CONDUCTED AS THE PROCEDURE DATE WAS UNKNOWN AND SITE INFORMATION IS UNCONFIRMED. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: PER A (B)(6) POST, A PATIENT UNDERWENT A DA VINCI-ASSISTED "DOUBLE HERNIA SURGERY" AND "WITHOUT ANY X-RAYS OF WHAT WAS GOING ON PRIOR." THE PATIENT STATED, "MY NECK HAS BEEN AN ISSUE SINCE 1998 WITHOUT ANY INTERVENTION ONLY REHAB AND CONSTANT RADIOLOGY?" ALTHOUGH THE PATIENT INDICATED THAT HE HAS HAD A NECK ISSUE SINCE 1998, IT IS UNCLEAR IF THE DA VINCI SURGICAL SYSTEM WAS A CONTRIBUTING FACTOR TO THE PATIENT'S NEED FOR REHAB AND CONSTANT RADIOLOGY. IT IS UNKNOWN IF THE REHAB AND CONSTANT RADIOLOGY WAS RENDERED BEFORE OR AFTER THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A (B)(6) POST FROM A PATIENT STATING, "I HAD DOUBLE HERNIA SURGERY FROM THE DA VINCI SURGICAL SYSTEM WITHOUT ANY X-RAYS OF WHAT WAS GOING ON PRIOR. MY NECK HAS BEEN AN ISSUE SINCE 1998 WITHOUT ANY INTERVENTION ONLY REHAB AND CONSTANT RADIOLOGY? MMM MAYBE RADIOLOGY TREATMENT." THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM/INSTRUMENT/ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. DUE TO THE NATURE OF THE COMPLAINT, ISI IS UNABLE TO CONTACT THE AUTHOR OF THE POST TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267414 DAVINCI SURGICAL SYSTEM DAVINCI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES