BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 13802195 · Received March 17, 2022

    Report

    Report Number
    2955842-2022-10647
    Event Type
    Injury
    Date Received
    March 17, 2022
    Date of Event
    January 31, 2022
    Report Date
    February 17, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE STAFF MEMBER'S FALL CANNOT BE DETERMINED. THE PROCEDURE WAS BEING PERFORMED IN A DARKENED ROOM FOR THE FIRST TIME AND THE NURSE TRIPPED ON A CABLE. THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO ISI FOR FAILURE ANALYSIS EVALUATION. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT/INCIDENT FROM THE CUSTOMER. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PROCEDURE, A STAFF MEMBER TRIPPED ON THE BLUE FIBER CABLE, WAS INJURED. AND CALLED IN SICK TO WORK. THE BLUE FIBER CABLE WAS NOT DAMAGED AND THERE WAS NO IMPACT ON THE SURGERY. THE STAFF MEMBER TRIPPED ON THE CABLE AS THE ROOM WAS DARKENED AT THE BEGINNING OF THE PROCEDURE. THERE IS NO ALLEGATION FROM THE CUSTOMER THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, A STAFF MEMBER TRIPPED OVER A BLUE FIBER CABLE AND BECAME INJURED. THE STAFF MEMBER CALLED IN SICK TO WORK. THE SURGICAL STAFF CONFIRMED THAT BLUE CABLE WAS NOT DAMAGED DURING THE INCIDENT AND THUS, THERE WAS NO NEED TO REPLACE THE CABLE OR CONSULT INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT. ISI FOLLOWED UP WITH THE ISI CLINICAL TERRITORY ASSOCIATE (CTA) AND OBTAINED THE FOLLOWING INFORMATION: THE LIGHTS IN THE OR WERE TURNED OFF FOR THE FIRST TIME WHEN THE INCIDENT OCCURRED. THE HOSPITAL NORMALLY PERFORMS ROBOTIC SURGERY WITH THE LIGHTS TURNED ON, HOWEVER THEY WANTED TO TRY LIGHTS OFF. THE NURSE WAS NOT A NEW STAFF AND SHE WAS AWARE THAT THERE WERE CORDS ON THE GROUND. SHE WAS WALKING AROUND THE ROOM WHEN SHE TRIPPED ON A BLUE FIBER CABLE. AFTER THE FALL, SHE SAT ON A CHAIR, HAD SOME WATER, AND RESTED. THE NURSE WAS NOT CARRYING ANYTHING WHEN SHE FELL DOWN. IT IS UNKNOWN WHAT INJURY THE NURSE SUSTAINED, WHETHER SHE UNDERWENT ANY INVESTIGATIONS, WHETHER SHE REQUIRED ANY HOSPITALIZATIONS DUE TO THE INJURY, HOW MANY DAYS THE STAFF CALLED IN SICK DUE TO THE INJURY, OR WHETHER SHE WAS ADVISED BY A MEDICAL PROFESSIONAL NOT TO RETURN TO WORK DUE TO THE INJURY. DEMOGRAPHIC INFORMATION REGARDING THE NURSE WAS ENQUIRED BUT NOT PROVIDED. ISI FOLLOWED UP WITH THE NURSE OF THE HOSPITAL BUT NO FURTHER INFORMATION ABOUT THE INCIDENT COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39255 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-39 N/A 00886874115404

    Patients

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