BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18520015 · Received January 16, 2024

    Report

    Report Number
    2955842-2024-10233
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    November 24, 2023
    Report Date
    December 20, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MAIN TUBE APPROXIMATELY 1.592" FROM THE DISTAL TIP, WHERE THE MAIN TUBE MEETS THE PROXIMAL CLEVIS. A PIECE MEASURING APPROXIMATELY 0.248¿ X 0.227¿ WAS NOT RETURNED WITH THE INSTRUMENT. THE ADJACENT COMPONENT WAS A DISLODGED PROXIMAL CLEVIS. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE THAT WAS RELATED TO THE PRIMARY FAILURE WAS THAT THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED PROXIMAL CLEVIS AT THE DISTAL END. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    AN 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 ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE COULD NOT BE DETERMINED AS THE PRODUCT WOULD NOT BEEN RETURNED FOR EVALUATION.

    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 NEPHRECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS (FBF) WERE INSERTED INTO THE TROCAR AND THE TIP WAS MISALIGNED. THE FBF WAS REMOVED. THE CUSTOMER USED THE EMERGENCY KEY, WHICH WAS UNABLE TO RESTORE THE AXIS. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING SURGERY WITH THE ROBOT, THE BIPOLAR FORCEPS BROKE INSIDE THE PATIENT, AT THE JUNCTION BETWEEN THE DISTAL METAL PART AND THE BODY OF THE ROBOT FORCEPS (MADE OF CARBON). THE BREAK CAUSED THE FORCEPS TO BEND, PREVENTING IT FROM EXITING THE TROCAR. THE EMERGENCY PROCEDURE HAD TO BE FOLLOWED, USING THE UNLOCKING KEY: THE FORCEPS OPENED, BUT THE CURVATURE REMAINED FIXED AND PERSISTENT. THE DEPARTMENT WAS THEREFORE OBLIGED TO UN-DOCK THE ROBOT AND REMOVE THE TROCAR WITH THE BIPOLAR FORCEPS JAMMED INSIDE. THE TEAM HAD TO AMPLIFY THE BREAKAGE IN ORDER TO RECOVER THE ROBOT TROCAR, WHICH CAUSED A LOT OF DEBRIS FROM THE BODY OF THE FORCEPS (CARBON PART) IN THE PATIENT, DIFFICULT TO VISUALIZE AS IT WAS OUT OF THE FIELD. THE OPERATING TIME WAS EXTENDED BY AROUND 20 MINUTES, THE TIME IT TOOK TO REMOVE THE FORCEPS AND REPLACE THEM WITH NEW ONES OF THE SAME REFERENCE, BUT THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT. THIS IS THE FIRST TIME AN INCIDENT OF THIS KIND HAS OCCURRED. IT SHOULD BE NOTED THAT THE FORCEPS ARE PRACTICALLY BRAND NEW, HAVING BEEN USED FOR ONLY THE SECOND TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853355 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K10230817 0393 00886874119808

    Patients

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