BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 14796498 · Received June 24, 2022

    Report

    Report Number
    2955842-2022-12361
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    May 11, 2021
    Report Date
    June 2, 2021
    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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF THE DATE OF THIS REPORT, THE INSTRUMENT HAS NOT BEEN RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED INCIDENT OF THE PORT SITE BURNS CANNOT BE DETERMINED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE SYSTEM LOGS FOR THE EVENT DATE OF (B)(6) 2021 HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) AND THE FOLLOWING WAS OBSERVED: THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND THE LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT REPORTEDLY EXPERIENCED POSTOPERATIVE BURN MARKS, IN THE LUMBAR SPINE AREA. MEDICAL INTERVENTION WAS PROVIDED TO THE PATIENT. IN THIS CASE, THE ROOT CAUSE OF THE REPORTED INCIDENT REMAINS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BURN MARKS. THE PROCEDURE WAS COMPLETED AS PLANNED. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CLINICAL SALES ASSOCIATE (CSA) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT HAD POSTOPERATIVE BURNS. THE BURNS COULD HAVE BEEN CAUSED BY THE ERBE VIO DV GENERATOR. THE BURNS MARKS APPEARED RED. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CLINICAL SALES ASSOCIATE (CSA) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE GENERATOR WAS USED IN SUBSEQUENT PROCEDURES. A FIELD SERVICE WAS CONDUCTED. DOCTORS AND LOCAL NURSES STILL BELIEVE THE PATIENT HAD TOO MUCH CLEANING (TOO HUMID) BEFORE THE OPERATION. IT WAS REPORTED THAT THE BURN WAS LOCATED IN THE LUMBAR SPINE AREA. THE BURN WAS NOT A SUPERFICIAL BURN. IT WAS REPORTED THAT THERE WAS MEDICAL INTERVENTION PROVIDED. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CLINICAL SALES ASSOCIATE (CSA) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT IS FINE, BUT THE CUSTOMER CANNOT PROVIDE FURTHER INFORMATION HOW THE PATIENT WAS TREATED POSTOPERATIVELY. IT WAS REPORTED THAT THE FIELD SERVICE ENGINEER (FSE) INDICATED THAT THERE WAS NOT A FAULT ON THE GENERATOR OR THE SYSTEM. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE FIELD SERVICE ENGINEER (FSE) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE LOGS FROM THE IESU AND DAV-SYSTEM WERE REVIEWED. NO ERRORS DURING THIS EFFECTED PROCEDURE. NO REPAIRS WERE PERFORMED ON THE SYSTEM. THE BIOMED DEPARTMENT AT WETZLAR REPORTED ¿THE PATIENT HAS NO BURNS [WHERE] THE GROUND PAD WAS FIXED.¿ IT LOOKS MORE [LIKE] MISUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455185 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-39 N/A 00886874115404

    Patients

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