BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16519387 · Received March 9, 2023

    Report

    Report Number
    2955842-2023-11209
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 14, 2023
    Report Date
    February 14, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. THE TSE DID NOT FIND ANY RELATED ERROR IN THE LOGS. THE TSE ADVISED TO RESEAT THE STERILE ADAPTER (SA) AND THE MCS INSTRUMENT OR TO REPLACE THE INSTRUMENT TO RESOLVE THE ISSUE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE PROBABLE ROOT CAUSE OF NON-INTUITIVE MOTION OF THE MCS INSTRUMENT IS ATTRIBUTED TO A LOOSELY CONNECTED, IMPROPERLY SEATED OF THE STERILE ADAPTER (SA) OR THE DEFECTIVE INSTRUMENT. THIS COMPLAINT IS CONSIDERED AS A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT HAD NON-INTUITIVE MOTION. 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 INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) THAT THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT MOVED SLIGHTLY INWARD WHEN IT WAS ACTIVATED. THE TSE DID NOT FIND ANY RELATED ERROR IN THE LOGS. THE TSE ADVISED TO RESEAT THE STERILE ADAPTER (SA) AND THE MCS INSTRUMENT OR TO REPLACE THE INSTRUMENT TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THERE WAS NO EXTERNAL COLLISION. THERE WAS A SLIGHT SHAKINESS WHEN THE MCS WAS ACTIVATED. THE ISSUE COULD NOT BE RESOLVED BY RESEATING THE SA AND THE MCS. THE SURGEON DID NOT REPLACE THE MCS WITH A NEW INSTRUMENT. THERE WAS NO PATIENT INJURY. THE MCS INSTRUMENT AND THE INSTRUMENT ARM DRAPE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435456 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K11220801 0362 00886874112298

    Patients

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