BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14859042 · Received June 29, 2022

    Report

    Report Number
    2955842-2022-12552
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    May 12, 2021
    Report Date
    July 12, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THIS EVENT FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A REVIEW OF THE SITE¿S COMPLAINT HISTORY DOES NOT REVEAL ANY RELATED COMPLAINTS INVOLVING THIS PRODUCT OR THIS EVENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE SYSTEM LOGS FOR THE EVENT DATE OF 12-MAY-2021 HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) POST MARKET SURVEILLANCE SPECIALIST 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 BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE SURGEON USED ETHICON STAPLE LINE REINFORCEMENT (SLR) BUTTRESS MATERIAL AND THERE WAS AN UNSPECIFIED LEAK. A SUREFORM 60 INSTRUMENT WAS ALSO IN USE DURING THE PROCEDURE. AN ANASTOMOTIC LEAK DUE TO UN-APPROXIMATED TISSUE, SURGICAL TECHNIQUES, ISCHEMIA (DUE TO BOTH VASCULAR INJURY AND/OR PATIENT PAST-MEDICAL HISTORY (I.E., VASCULAR DISEASE OR NUTRITIONAL DEFICIENCIES)), PATIENT ANATOMY (I.E., ANASTOMOTIC TENSION) FOLLOWING SLEEVE GASTRECTOMY WOULD BE ¿LIFE-THREATENING¿ IF OTHERWISE LEFT UNTREATED VIA MEDICAL OR SURGICAL INTERVENTION. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON TRIED ETHICON STAPLE LINE REINFORCEMENT (SLR) BUTTRESS MATERIAL AND THERE WAS AN UNSPECIFIED LEAK. ON 28-JUL-2021 INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM AN ISI PROJECT MANAGER (PM) WHO REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE SURGEON USED ETHICON STAPLE LINE REINFORCEMENT (SLR) BUTTRESS MATERIAL AND THERE WAS AN UNSPECIFIED LEAK. A SUREFORM 60 INSTRUMENT WAS ALSO IN USE DURING THE PROCEDURE. ISI HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE. THE ISI REPRESENTATIVE COMMUNICATED THOSE ADDITIONAL DETAILS ARE NOT BEING PROVIDED BY THE SITE AND ARE UNATTAINABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089987 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A 00886874110720

    Patients

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