BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 12098135 · Received July 1, 2021

    Report

    Report Number
    2955842-2021-10728
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    May 31, 2021
    Report Date
    June 5, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT INVOLVED WITH THIS COMPLAINT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE VSE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2021. THERE WERE NO ERRORS OR EVENT SEQUENCES THAT WOULD SUGGEST AN INSTRUMENT FAILURE. THE VSE, WHICH IS A SINGLE-USE INSTRUMENT, WAS CONFIRMED TO HAVE BEEN USED ON (B)(6) 2021. A REVIEW OF THE SITE'S COMPLAINT HISTORY REVEALS NO OTHER COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGES OR PROCEDURE VIDEO WERE PROVIDED FOR REVIEW. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING WARNINGS: THE VESSEL SEALER EXTEND INSTRUMENT IS INTENDED FOR GRASPING AND BLUNT DISSECTION OF TISSUE AND FOR BIPOLAR COAGULATION AND MECHANICAL TRANSECTION OF VESSELS UP TO 7 MM IN DIAMETER AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. WHEN FUNCTIONING PROPERLY, THE INSTRUMENT HAS BOTH VISUAL (TISSUE EFFECT) AND AUDIO (TONES FROM THE GENERATOR) CUES THAT PROVIDE FEEDBACK TO THE USER THAT IT IS OPERATING AS INTENDED. MAKE SURE THAT THE TISSUE IS COMPLETELY SEALED BEFORE CUTTING. IF SEALING FAILURE IS FOUND, BLEEDING DURING CUTTING CAN BE PREVENTED BY RESEALING, SO THERE IS NO RISK OF SERIOUS HEALTH DAMAGE. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT FIVE HOURS AFTER A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY SURGICAL PROCEDURE FOR ESOPHAGEAL CANCER, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING. AS A RESULT THE PATIENT UNDERWENT A SECOND PROCEDURE TO ADDRESS THE BLEEDING. THE SURGEON STATED THAT THE POSSIBLE CAUSES FOR THE POST-OPERATIVE BLEEDING WERE: INCREASE IN THE PATIENT'S BLOOD PRESSURE TO ABOUT 160/170 MMHG AFTER THE SURGERY, OR AN INADEQUATE SEAL DURING THE PROCEDURE. THE VSE INSTRUMENT THAT WAS USED DURING THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS. THE CAUSE OF THE REPORTED POST-OPERATIVE COMPLICATION IS NOT ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT IN HER 60S UNDERWENT A DA VINCI-ASSISTED TRANSTHORACIC ESOPHAGECTOMY SURGICAL PROCEDURE FOR ESOPHAGEAL CANCER. FIVE HOURS AFTER THE PROCEDURE THERE WAS BLOOD IDENTIFIED IN THE CHEST DRAIN. AN X-RAY CONFIRMED THAT BLOOD HAD ACCUMULATED IN THE THORACIC CAVITY. AS A RESULT, THE PATIENT UNDERWENT AN UNSPECIFIED SECOND PROCEDURE. BLEEDING FROM THE BRANCH OF THE RIGHT BRONCHUS (ABOUT 0.5 MM) WAS CONFIRMED. THE SURGEON USED CAUTERY TO ADDRESS THE BLEEDING. THE SURGEON STATED THE FOLLOWING POSSIBLE CAUSES FOR THE POST-OPERATIVE BLEEDING: THE FIRST POSSIBLE CAUSE IS THAT THE PATIENT'S BLOOD PRESSURE HAD INCREASED AFTER THE SURGERY TO ABOUT 160/170 MMHG. THE SECOND POSSIBLE CAUSE MAY BE DUE TO AN INADEQUATE SEAL. AFTER CAUTERIZATION AND DISSECTION WITH A VESSEL SEALER EXTEND (VSE) INSTRUMENT, "FIBROUS MATERIAL REMAINED." AS A RESULT, THE SURGEON APPLIED "TENSION" AND USED A MARYLAND BIPOLAR FORCEPS INSTRUMENT TO CAUTERIZE AND CUT THE FIBROUS MATERIAL. ALTHOUGH THE SURGEON REPORTED TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THAT HE DID NOT THINK THERE WAS A LACK OF VSE SEALING; HE ALSO STATED THAT HE COULD NOT DENY THE POSSIBILITY OF AN INSUFFICIENT SEAL. IT WAS REPORTED THAT THE PATIENT WAS RECOVERING WELL. ISI WAS NOT ABLE TO RECEIVE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED INCIDENT AND PATIENT DETAILS AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999733 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 M91201117 0122 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR