BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 17388354 · Received July 25, 2023

    Report

    Report Number
    2955842-2023-17275
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 3, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO VISIBLE DAMAGE WAS OBSERVED. THE SURGICAL TASK BEING PERFORMED WAS DISSECTING. THE CUSTOMER WAS MOVING THE CAMERA, AND THE INSTRUMENT WENT OUT OF VIEW. THE CUSTOMER DID NOT BELIEVE THAT THE INSTRUMENT HIT THE CAMERA. THE CUSTOMER WAS ZOOMING OUT AND THEN THE ARM SNAPPED OUT OF VIEW. IT HAS TO HAVE BEEN BROKEN AGAINST ANOTHER ARM, AND THE MALFUNCTION WAS THE QUICK JUMP OF THE HAND WHEN THE CUSTOMER WAS MOVING THE CAMERA. IT WAS IN USE FOR ABOUT AN HOUR. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE FRAGMENTS WERE A RESULT OF THE INSTRUMENT BREAKING, NOT A COLLISION. IT WAS NOT REMOVED BEFORE THE INCIDENT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE WRIST WAS NOT STRAIGHTENED. THE INSTRUMENT COULD NOT COME OUT OF THE CANNULA AS IT IS AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. ONCE REMOVED AND OFF THE STERILE FIELD, THE INSTRUMENT TIP HAD TO BE BROKEN OFF TO REMOVE IT FROM THE CANNULA. THE SURGEON USED A NEW FORCE BIPOLAR TO GRASP EACH FRAGMENT AND THE ASSIST CAME IN WITH A LAPAROSCOPIC NEEDLE DRIVER TO RETRIEVE THE FRAGMENTS THROUGH A CANNULA. ALL THE FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. AN X-RAY WAS PERFORMED AT THE END OF THE CASE. THE PROCEDURE WAS ROBOTICALLY COMPLETED WITH NO PATIENT INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO ANY POST SURGICAL COMPLICATIONS. AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 8MM FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED. THE INSTRUMENT WAS FOUND TO HAVE THE MAIN TUBE BROKEN. A PIECE MEASURING APPROXIMATELY 0.240¿ X 0.351¿ WAS NOT RETURNED WITH THE INSTRUMENT. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE WERE ALSO OBSERVED. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP CABLE AT THE DISTAL END. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END WITH NO MATERIAL MISSING. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP. THE DISTAL END WAS BROKEN AWAY FROM THE INSTRUMENT AND THE DISTAL END WAS RETURNED. THE REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN INSTRUMENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE CUSTOMER LOST VISUAL SIGHT OF THE FORCE BIPOLAR FOR A FEW SECONDS. ONCE IT CAME INTO VIEW, THE TIP OF THE FORCE BIPOLAR INSTRUMENT WAS BROKEN, AND 2 SMALL PLASTIC PIECES CAME OFF. THE CUSTOMER WAS NOT ABLE TO TAKE THE INSTRUMENT OUT AS USUAL AND HAD TO REMOVE THE TROCAR WITH THE INSTRUMENT TOGETHER TO GET IT OUT. THE CUSTOMER THEN PUT IN ANOTHER TROCAR AND PROCEEDED WITH THE CASE. ONCE THE TROCAR AND INSTRUMENT WERE OUT, THE CUSTOMER DID HAVE TO BREAK THE TIP OFF TO GET THE INSTRUMENT OUT OF THE TROCAR. IT WAS INDICATED THAT THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369123 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K13230226 0028 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES