BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16971280 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-13935
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    July 29, 2021
    Report Date
    August 13, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119778
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CADIERE FORCEPS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE REPORTED ISSUE. THE CADIERE FORCEPS WAS FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY 0.21" X 0.69" WAS FOUND TO BE BROKEN OFF THE YAW PULLEY. THE BROKEN FRAGMENT WAS NOT RETURNED WITH THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, ONE OF THE PIECES OF THE CADIERE FORCEPS BROKE OFF. THE CUSTOMER REPORTED THAT THEY DID NOT FIND FRAGMENT; HOWEVER, TOOK AN XRAY OF THE PATIENT AND STATED IT WAS NOT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THEY NOTICED A PIECE WAS MISSING IN SPD AFTER THE INSTRUMENT WAS REMOVED FROM THE WASH. THE SURGEON WAS UNAWARE OF THE INITIAL BREAK BECAUSE IT WAS NEVER VISUALIZED BY THE SURGEON. THE SURGEON DID NOT USE THE CADIERE FORCEPS FOR LONG BECAUSE HE PREFERS TO USE THE FORCE BIPOLAR INSTRUMENT. THE SURGEON SAID HE FELT THE CADIERE FORCEPS DID NOT GRASP THE TISSUE WELL SO HE ENDED UP USING THE FORCE BIPOLAR INSTRUMENT. THE CADIERE FORCEPS DID NOT COLLIDE WIT ANOTHER INSTRUMENT OR ANY OTHER HARD MATERIAL DURING THE PROCEDURE. HE HAS NOT HEARD OF ANY INJURY TO THE PATIENT AT THIS TIME. THE STAFF DOES NOT KNOW WHERE THE FRAGMENT FELL. THEY DO NOT BELIEVE IT IS IN THE PATIENT BECAUSE IT WAS CLEARED BY RADIOLOGY. THE PATIENT IS A WHITE 30 YEAR OLD FEMALE WEIGHING 227 LBS. 2 VIEW X-RAYS WERE PERFORMED ON THE PATIENT ON (B)(6) 2021. ON 24-AUG-2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MEDWATCH 5102934 STATING: "FORCEP TIP OF CADIERE ROBOTIC FORCEP DETACHED FROM WORKING ELEMENT AT SOME POINT DURING USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862511 ENDOWRIST CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 471049-07 N11200525 0001 00886874119778

    Patients

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