BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15555735 · Received October 6, 2022

    Report

    Report Number
    2955842-2022-14418
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 7, 2022
    Report Date
    September 7, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS ADDRESSED WITH PHONE SUPPORT. THE TECHNICAL SUPPORT ENGINEER (TSE) REQUESTED THE CUSTOMER TO RESEAT THE STERILE ADAPTER AND TRY A SECONDARY INSTRUMENT TO VERIFY CONTROLS. THE CUSTOMER OPTED TO INSTALL A NEW VESSEL SEALER AND THE NEW VESSEL SEALER WORKED WITH NO ISSUES. THE TSE REQUESTED THE CUSTOMER TO RETURN MATERIAL AUTHORIZATION (RMA) THE VESSEL SEALER EXTEND (VSE) FOR FURTHER ANALYSIS. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED. THE VSE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. FOLLOW-UP MDR WILL BE SUBMITTED (POST-EVALUATION) AND/OR IF ADDITIONAL INFORMATION IS OBTAINED. AN PROCEDURE LOG WAS PERFORMED TO CONFIRM THAT THE LOW ANTERIOR RESECTION PROCEDURE WAS PERFORMED ON (B)(6) 2022 VIA SYSTEM (B)(4). NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS CONSIDERED AS A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE VSE INSTRUMENT MOVED WITH UNINTUITIVE MOTION (E.G. THE INSTRUMENT UNEXPECTEDLY JERKED/JUMPED/SWUNG/BOWED, MOVED IN AN UNEXPECTED/UNINTENDED/UNKNOWN WAY). UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. 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 · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THE SURGEON¿S LEFT-HAND CONTROL SEEMED TO BE INVERTED OR FLIPPED. THE CUSTOMER STATED THAT THEY RESEATED THE VESSEL SEALER INSTRUMENT AND THE COMERS PRIOR TO CALLING IN. THE TSE REQUESTED THE CUSTOMER TO RESEAT THE STERILE ADAPTER AND TRY A SECONDARY INSTRUMENT TO VERIFY CONTROLS. THE CUSTOMER OPTED TO INSTALL A NEW VESSEL SEALER INSTRUMENT AND THE NEW VESSEL SEALER WORKED WITH NO ISSUES. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS THE ROBOTIC COLECTOMY WITH DIVERTING LOOP ILEOSTOMY. THE DA VINCI COORDINATOR NURSE WILL SEND THE REQUESTED FOLLOW UP TO THE NURSE THAT WAS IN THE ROOM TO SEE IF THEY WILL BE ABLE TO HELP ASSIST WITH ANY MORE INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505205 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422 N/A

    Patients

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