BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10956840 · Received December 7, 2020

    Report

    Report Number
    2955842-2020-11319
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 12, 2020
    Report Date
    November 13, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VESSEL SEALER EXTEND INSTRUMENT INVOLVED IN THIS COMPLAINT HAS NOT BEEN RETURNED TO ISI FOR ANALYSIS. IF THE PRODUCT IS RETURNED AND/OR IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. SITE HISTORY REVIEW: A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. PRODUCT AND EVENT VERIFICATION: VERIFICATION OF THE PRODUCT AND EVENT DETAILS CANNOT BE PERFORMED VIA SYSTEM LOGS BECAUSE THE SITE DID NOT HAVE THE SYSTEM CONNECTED TO THE NETWORK. IMAGE/VIDEO REVIEW: NO IMAGE OR VIDEO WAS PROVIDED. THE VESSEL SEALER EXTEND 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. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE GENERATOR USED WITH THE VESSEL SEALER EXTEND INSTRUMENT AND DA VINCI SYSTEM IS DESIGNED TO PROVIDE A SUCCESSFUL CONFIRMATION SIGNAL TO INDICATE SEAL COMPLETION. HOWEVER, IT IS UNKNOWN IF THERE WAS A SUCCESSFUL CONFIRMATION SIGNAL FOLLOWING THE REPORTED SEALING CYCLE ATTEMPT. THE VESSEL SEALER EXTEND INSTRUMENT REPORTEDLY DID NOT SUFFICIENTLY COMPLETE A SEAL AND IT IS UNKNOWN IF THERE WERE AUDIBLE BEEPS FROM THE GENERATOR, INDICATING THAT THE SEAL WAS COMPLETE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE THE VESSEL SEALER EXTEND STOPPED CAUTERIZING, BUT THE CUTTING WAS NOT AFFECTED. THE SITE REPORTED A BACK-UP VESSEL SEALER EXTEND WAS USED TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS. THIS COMPLAINT WILL BE CLASSIFIED BASED ON THE PROVIDED INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422146 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L92200728 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR