BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 11936097 · Received June 3, 2021

    Report

    Report Number
    2955842-2021-10612
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 10, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K180351
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED OR IS UNKNOWN. ISI HAS REQUESTED THE FORCE BIPOLAR INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION BUT AT THIS TIME THE INSTRUMENT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SITE COMPLAINT HISTORY REVIEW WAS CONDUCTED AND SHOWED NO ADDITIONAL ISSUES REPORTED FOR THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. SYSTEM ERROR LOG REVIEW WAS CONDUCTED FOR A PROCEDURE ON (B)(6) 2021 ON SYSTEM (B)(4). WHILE THERE WERE VARIOUS TOOL ENGAGEMENT, TRUMPF TABLE, AND COMMUNICATION MESSAGES, THERE WERE NO OBSERVED RELATED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. A REVIEW OF THE INSTRUMENT LOGS WAS ALSO PERFORMED. FORCE BIPOLAR INSTRUMENT PN: 471405-06 // LN: N112103080055 // SN: (B)(4) WAS RECORDED AS BEING USED ONCE DURING THE PROCEDURE, WAS IN USE FOR 0:11:15 MINUTES, HAD 8 OF 12 USES REMAINING, AND WAS USED IN A SUBSEQUENT PROCEDURE ON (B)(6) 2021. ALL REUSABLE INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES AND A SITE COMPLAINT REVIEW SHOWS NO COMPLAINT FILED AGAINST ANY OF THE INSTRUMENTS. WHILE THE SURGEON OF RECORD INITIALLY INDICATED THAT THE ¿UNINTENTIONAL CUTS IN THE COLON¿ AND THE PROCEDURE CONVERSION TO OPEN SURGERY WERE DUE TO THE PATIENT¿S MEDICAL HISTORY AND THE ¿UNHEALTHY CONDITION OF THE PATIENT'S BOWEL¿, THE SURGEON LATER TOLD AN ISI TRAINER THAT THERE WAS AN ALLEGATION OF AN ISSUE DURING USE OF A FORCE BIPOLAR INSTRUMENT LEADING TO AN ADVERSE EVENT. LOG REVIEW FOUND THAT THE FORCE BIPOLAR INSTRUMENT USED DURING THIS PROCEDURE WAS USED IN A SUBSEQUENT PROCEDURE WITH NO ADDITIONAL COMPLAINT FILED AGAINST THE INSTRUMENT. WHILE THERE IS NO ALLEGATION OF A PRODUCT ISSUE THAT WOULD BE CLASSIFIED AS A REPORTABLE MALFUNCTION, THE DESCRIBED EVENT MEETS THE CRITERIA OF A REPORTABLE ADVERSE EVENT. THE SURGEON ALLEGEDLY INITIALLY THOUGHT THAT HE ACCIDENTALLY WENT INTO STRONG GRIP MODE WITHOUT KNOWING IT WHICH RESULTED IN ¿THE TWO SMALL COLON INJURIES¿. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE PROCEDURE CONVERSION, ALLEGED FAILURE MODE, AND MEDICAL INTERVENTION REQUIRED TO REPAIR THE COLON INJURIES ARE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED LYSIS OF ADHESIONS PROCEDURE ON (B)(6) 21, THE SURGEON WAS ¿USING A FORCE BIPOLAR INSTRUMENT ON THE COLON AND ENTEROTOMY OCCURRED¿. THE SURGEON WAS "USING FORCE BIPOLAR ON THE COLON JUST TO MOVE THE COLON OUT OF THE WAY¿ AND ¿UPON GRABBING THE COLON, TWO UNPLANNED NEUROTOMES OCCURRED¿. IT WAS UNKNOWN IF THE INTRA-OPERATIVE COMPLICATIONS WERE DUE TO THE PATIENT'S BOWEL HEALTH AND/OR SURGEON TECHNIQUE/USAGE OF THE DA VINCI INSTRUMENT. THE ¿PATIENT HARM THAT WAS REPORTED¿ WAS THAT THE ¿PATIENT HAD TO BE CONVERTED TO OPEN SURGERY¿. ON (B)(6) 2024, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: WITHIN THE FIRST 45 MINUTES DURING A DA VINCI-ASSISTED LYSIS OF ADHESIONS PROCEDURE ON (B)(6) 21; ON A FEMALE PATIENT WITH A PRIOR SURGICAL HISTORY OF GASTRIC BYPASS SURGERY ON AN UNKNOWN PREVIOUS DATE, THE PROCEDURE CONVERTED TO OPEN SURGERY DUE TO TWO SMALL CUTS ON THE COLON. IT WAS REPORTED THAT THE PATIENT¿S ¿BOWEL HAD LOOPED AROUND AN ADHESION¿. THE SURGEON WAS USING A FORCE BIPOLAR INSTRUMENT TO ¿MOVE THE COLON OUT OF THE WAY¿ BUT UPON ¿GRABBING THE COLON¿, THE SURGEON ¿MADE TWO SMALL UNINTENTIONAL CUTS¿ IN COLON TISSUE. THE SURGEON APPLIED ONE SUTURE TO ONE OF THE SMALL ¿CUTS¿ BUT UPON TRYING TO APPLY A SUTURE IN THE SECOND SMALL CUT, THE SURGEON WAS NOT HAPPY WITH THE V-LOC SUTURE AS IT WAS NOT ¿HOLDING¿. THE PROCEDURE CONVERTED TO OPEN SURGERY. THE SURGEON REPAIRED THE COLON BY UNKNOWN MEANS. THE PATIENT WAS DISCHARGED HOME AND WAS REPORTED AS DOING WELL. ISI HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832949 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 N11210308 0055 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1