BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 11713341 · Received April 23, 2021

    Report

    Report Number
    2955842-2021-10429
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 22, 2021
    Report Date
    March 27, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112380
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    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. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SITE HISTORY REVIEW WAS CONDUCTED ON (B)(6) 2021 AND AGAIN ON (B)(6) 2021 AND DID NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS EVENT. PROCEDURE VIDEO: IT WAS REPORTED THAT A VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE BUT THE SURGEON/SITE HAS NOT SUBMITTED THE VIDEO FOR REVIEW. INTUITIVE SURGICAL, INC. (ISI) HAS REACHED OUT TO THE CUSTOMER TO BOTH OBTAIN ADDITIONAL INFORMATION AND A COPY OF THE PROCEDURE VIDEO, BUT ISI HAS NOT YET RECEIVED A RESPONSE. UPON FOLLOW-UP, THE CONSOLE SURGEON WAS UNABLE TO DISTINGUISH PATIENT DETAILS WITH EVENT DETAILS AND THE SPECIFIC TREATMENT NEEDED FOR THE PATIENT. AN MDR IS BEING SUBMITTED FOR BOTH EVENTS. REFER TO THE REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE OTHER EVENT. SYSTEM ERROR LOG REVIEW WAS CONDUCTED FOR A PROCEDURE ON (B)(6) 2021 ON SYSTEM SK4103. WHILE THERE WERE VARIOUS TOOL ENGAGEMENT AND OTHER MESSAGES, THERE WERE NO OBSERVED 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 PERFORMED ON (B)(6) 2021 FOR A PROCEDURE ON (B)(6) 2021 ON SYSTEM SK4103. THERE WERE TWO CLIP APPLIER INSTRUMENTS IN USE DURING THIS PROCEDURE: LARGE CLIP APPLIER #1 PN: 470230-12 // LN: N10190513-0015 // SN: (B)(4) WITH 50 OF 100 USES REMAINING AND LARGE CLIP APPLIER #2 PN: 470230-12 // LN: N10201110-0067 // SN: (B)(4) WITH 96 OF 100 USES REMAINING. IT WAS OBSERVED THAT THE SECOND CLIP APPLIER INSTRUMENT WAS USED IN A SUBSEQUENT PROCEDURE. WHILE NOT ALL REUSABLE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES AT THIS TIME, A SITE HISTORY SEARCH SHOWS NO COMPLAINTS FILED AGAINST THOSE INSTRUMENTS. AT THIS TIME, THE DESCRIBED EVENT MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THE EVENT DETAILS ACKNOWLEDGE THAT A LARGE CLIP APPLIER INSTRUMENT WAS USED DURING PROCEDURE WITH A PATIENT INVOLVED. THE SURGEON LATER ALLEGED A GENERALIZED UNSPECIFIED ISSUE APPLYING CLIPS WITH A LARGE CLIP APPLIER INSTRUMENT AFTER THE POST-OPERATIVE CYSTIC DUCT LEAK HAD BEEN IDENTIFIED. FURTHER, THE DESCRIBED EVENT MEETS THE CRITERIA OF A REPORTABLE ADVERSE EVENT. PATIENT DETAILS WERE UNKNOWN AND/OR UNCONFIRMED. THE BRAND OF CLIPS USED IN THE PROCEDURE WERE UNKNOWN. IT WAS UNKNOWN HOW MANY CLIPS THE SURGEON ATTEMPTED TO USE, AND WHERE. IT WAS UNKNOWN ON WHAT SIZE OF DUCT THE CLIPS WERE USED. THE SEVERITY OF THE POST-OPERATIVE CYSTIC DUCT LEAK AND THE TYPE OF REQUIRED MEDICAL INTERVENTION WAS UNKNOWN. IT WAS UNKNOWN IF A SECOND PROCEDURE WAS REQUIRED TO RESOLVE THE ISSUE. IT WAS UNKNOWN IF A CLIP THAT WAS INITIALLY SECURED AND THEN LATER CAME OFF. ADDITIONALLY, AT THIS TIME, THE ROOT CAUSE OF THE REPORTED ISSUE IS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE (2020 REPORTS) IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN INITIAL REPORTER IS NOT AVAILABLE. FIELDS PMA/510K (2020 REPORTS), ADVERSE EVENT, RECALL (IF RECALL NUMBER IS GIVEN) OR CORRECTION/REMOVAL NUMBER (IF GIVEN) (2021 REPORTS), AND CORRECTION/REMOVAL NUMBER (2020 REPORTS) ARE NOT APPLICABLE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AFTER A SUCCESSFULLY COMPLETED DA VINCI-ASSISTED DISTAL GASTRECTOMY PROCEDURE ON (B)(6) 2021, THERE WAS A REPORT OF A POST-OPERATIVE CYSTIC DUCT LEAK ON AN UNSPECIFIED DATE. WHILE THERE WAS NO INITIAL REPORT OF A SYSTEM, INSTRUMENT, OR ACCESSORY ISSUE DURING THE DA VINCI PROCEDURE, THE SURGEON LATER ALLEGED A GENERALIZED UNSPECIFIED ISSUE APPLYING CLIPS WITH A LARGE CLIP APPLIER INSTRUMENT AFTER THE POST-OPERATIVE CYSTIC DUCT LEAK HAD BEEN IDENTIFIED. IT WAS NOTED THAT THERE WAS AN ALLEGATION OF TWO SIMILAR SEPARATE AND UNRELATED EVENTS. ON 17-APR-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CONSOLE SURGEON WHO SAID THAT FOR ONE PATIENT WE ULTIMATELY CONFIRMED IT WAS FROM THE CYSTIC DUCT AND I WAS CONCERNED THAT THE CLIPS SLIPPED. I LOOKED INTO WHAT TYPE OF CLIP WE USE AND THERE WERE NO IRREGULARITIES." FOR THE OTHER PATIENT, THE SURGEON SAID, WE COULDN'T CONFIRM IF IT WAS A CYSTIC DUCT LEAK BUT ULTIMATELY IT BEHAVED LIKE A DUCT OF LUSCHKA LEAK AND HAS HEALED ONLY WITH DRAINAGE." THE SURGEON ALSO SAID, "OVERALL, I DO NOT BELIEVE THOSE INCIDENTS WERE RELATED TO THE CLIPS AND CERTAINLY NOT THE ROBOT. WHILE THE SURGEON WAS UNABLE TO CONFIRM WHICH PATIENT WAS RELATED TO WHICH EVENT AT WHICH SITE, IT WAS CONFIRMED THAT THE PATIENTS ARE DOING WELL. ADDITIONAL DETAIL REGARDING MEDICAL INTERVENTION WAS NOT DISCLOSED AND THE FOLLOWING WAS UNKNOWN: PATIENT DETAILS WERE UNKNOWN/UNCONFIRMED; WHICH PATIENT WAS RELATED TO WHICH EVENT AT WHICH SITE. THE BRAND OF CLIPS USED IN THE PROCEDURE WERE UNKNOWN. IT WAS UNKNOWN HOW MANY CLIPS THE SURGEON ATTEMPTED TO USE, AND WHERE. IT WAS UNKNOWN WHAT SIZE OF DUCT. THE SEVERITY OF THE POST-OPERATIVE CYSTIC DUCT LEAK AND THE TYPE OF REQUIRED MEDICAL INTERVENTION WAS UNKNOWN. IT WAS UNKNOWN IF A SECOND PROCEDURE WAS REQUIRED TO RESOLVE THE ISSUE. IT WAS UNKNOWN IF A CLIP THAT WAS INITIALLY SECURED AND THEN LATER CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615569 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 N10190513 0015 00886874112380

    Patients

    Seq Age Sex Outcome Treatment
    1