BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16660694 · Received March 31, 2023

    Report

    Report Number
    2955842-2023-11697
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    February 22, 2023
    Report Date
    March 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DIFFICULTIES OPENING AND CLOSING, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: PER THE DESCRIPTION OF THE COMPLAINT, THE CLIP APPLIER MAY HAVE INCURRED A FAILURE MODE THAT IS KNOWN TO IMPACT CLIP APPLICATION EFFECTIVENESS. DEFICIENCIES IN CLIP APPLICATION MAY LEAD TO INADEQUATE HEMOSTASIS. 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE CLIP APPLIER INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS/TIPS (FOR SCISSORS) OPENED AND CLOSED PROPERLY. NO NON-INTUITIVE MOTION WAS OBSERVED. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS ALSO IDENTIFIED. THE CLIP APPLIER INSTRUMENT WAS FOUND WITH ONE GRIP BENT. THE DAMAGE WAS FOUND NEAR THE BASE OF THE CLIP GROOVE, CAUSING A 0.024" OFFSET AT THE TIPS. AS A RESULT, THE CLIP COULD BE LOADED ON THE GRIPS BUT WAS UNABLE TO RELEASE THE CLIP FROM THE TUBING ON ONE SIDE OF GRIP TIPS DURING IN-HOUSE TESTING AFTER MULTIPLE ATTEMPTS. THE INSTRUMENT FAILED THE CLIP TEST. THE MOST COMMON CAUSES OF THE FAILURE MODE BENT-SEVERELY INSTRUMENT GRIPS -TIPS ARE TYPICALLY ATTRIBUTED TO THE MISHANDLING/MISUSE, SUCH AS EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS. SEVERELY BENT GRIPS ARE ATTRIBUTED TO DAMAGE DURING EITHER USE OR REPROCESSING, AS SEVERE MISALIGNMENT OF GRIP TIPS CAN BE DUE TO ACCIDENTAL DROPS, INCORRECT INSTRUMENT TRAY OR SINK SIZES FOR REPROCESSING, OR OVERLOADING THE TIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER WAS DIFFICULT TO OPEN AND CLOSE. THE MOVEMENT OF THE INSTRUMENT IS RESTRICTED. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED, AND THE PROCEDURE WAS COMPLETED WITH A SPARE INSTRUMENT WITH NO PATIENT HARM AND NO DELAYS. INTUITIVE SURGICAL (IS) CONTACTED THE SITE/REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE CLIP APPLIER HAD A LIMITED FUNCTION. THE INSTRUMENT WAS CHECKED BEFORE USE AND NO ABNORMALITIES BEFORE USE, THE CLIP APPLIER COULD BE INSERTED AS USUAL. THE USE OF HEM-O-LOCK CLIPS WAS THE TYPE OF CLIPS THAT WERE USED WITH THE CLIP APPLICATOR. ML WAS THE SIZE CLIP THAT THE SURGEON USED ON THE VESSEL OR STRUCTURE. THE SURGEON CONFIRMS THAT THERE WAS A BAD OPENING AND INSUFFICIENT CLOSING OF THE CLIP APPLIER. THE VESSEL WAS NOT LARGER THAN 13 MM IN DIAMETER.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774600 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K10220208 0184 00886874112465

    Patients

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