BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15741074 · Received November 5, 2022

    Report

    Report Number
    2955842-2022-15107
    Event Type
    Malfunction
    Date Received
    November 5, 2022
    Date of Event
    October 6, 2022
    Report Date
    October 6, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K180351
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FAILURE ANALYSIS INVESTIGATION WAS OBTAINED: INITIAL FINDINGS WERE CONFIRMED. A CLOSER LOOK WAS TAKEN AT THE SURFACE STRUCTURE WHERE THE BREAK OCCURRED. NO CRACKS OR HOLES WERE OBSERVED ON THE SURFACE. IT IS MORE LIKELY THAT THE BROKEN GRIP TIP WAS A RESULT OF USER MISHANDLING SUCH AS OVERLOADING THE INSTRUMENT TIPS. THE ROOT CAUSE OF THE FAILURE IS ATTRIBUTED TO THE MISHANDLING/MISUSE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FORCE BIPOLAR FOR EVALUATION AND THE FAILURE ANALYSIS HAS BEEN COMPLETED. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIPS TIP, BROKEN AT THE GRIP BASE. THE GRIP WAS BROKEN OFF, BUT WAS STILL ATTACHED TO THE CONDUCTOR WIRE. AS A RESULT OF THE BREAKAGE, MANUAL ARTICULATION OF THE INPUTS FOUND THE GRIP'S INTUITIVE MOTION TO NOT FUNCTION PROPERLY. THE INSTRUMENT WAS NOT TESTED FOR FUNCTIONALITY ON THE SYSTEM DUE TO THE BROKEN GRIP. THERE WERE NO PIECES MISSING FROM THE BREAKAGE. COMMON CAUSES OF THE FAILURE MODE BROKEN INSTRUMENT GRIPS -TIPS ARE TYPICALLY ATTRIBUTED TO THE USER, SUCH AS EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS. THIS DAMAGE MAY BE ATTRIBUTED TO EITHER DEVICE DESIGN OR USE CONDITIONS. REGARDING DEVICE DESIGN, FRAGMENTS CAN RESULT AS RETENTION OF THE METAL INJECTION MOLDING (MIM) TO THE OVERMOLD (OM) IS INSUFFICIENT. REGARDING USE, DAMAGE TO THE FORCE BIPOLAR INSTRUMENT CAN OCCUR WHILE PERFORMING ¿OFF-LABEL¿ SURGICAL APPLICATIONS, SUCH AS NEEDLE BENDING/DRIVING AND SUTURE SNAPPING, MISHANDLING THE INSTRUMENT CAUSING COLLISIONS, AND MISUSING THE INSTRUMENT. A REVIEW OF THE PROCEDURE LOG SHOWED THE FORCE BIPOLAR WAS LAST USED ON (B)(6) 2022 ON SYSTEM (B)(4). THE INSTRUMENT HAD 6 LIVES REMAINING. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE FORCE BIPOLAR INSTRUMENT MOVED WITH UNINTUITIVE MOTION (E.G. THE INSTRUMENT UNEXPECTEDLY JERKED/JUMPED/SWUNG/BOWED, MOVED IN AN UNEXPECTED/UNINTENDED/UNKNOWN WAY). FAILURE ANALYSIS WAS PERFORMED AND FOUND THAT THE INSTRUMENT HAD A BROKEN GRIP AND, AS A RESULT, THE MANUAL ARTICULATION OF THE INPUTS FOUND THE GRIP'S INTUITIVE MOTION TO NOT FUNCTION PROPERLY. THERE WAS NO ALLEGATION OF A FRAGMENT FALLING INSIDE THE PATIENT, BUT THE BROKEN GRIP COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, REQUIRING AN ADDITIONAL SURGICAL PROCEDURE TO RETRIEVE THE FRAGMENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    THE FORCE BIPOLAR INSTRUMENT WAS RETURNED, NOTING THAT THERE WAS NON-INTUITIVE MOTION. THE UNKNOWN PROCEDURE TYPE WAS REPORTEDLY COMPLETED WITH NO REPORTED INJURY. 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
    2334419 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10220620 0671 00886874120767

    Patients

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