BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17574167 · Received August 18, 2023

    Report

    Report Number
    2955842-2023-17832
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 13, 2023
    Report Date
    July 24, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED ADDITIONAL INFORMATION. THE BREAKAGE WAS ON THE DISTAL END OF THE INSTRUMENT THAT ENTERS THE PATIENT. THE LOOSE PIECES WERE RETURNED. ISI RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED. THE INSTRUMENT WAS FOUND TO HAVE TWO BACK END IDLER PULLEYS DISLODGED FROM THE PIN AT THE FLUSH TUBE GUIDE / WATER FALL LOCATION IN THE PROXIMAL END (IN THE HOUSING). BOTH IDLER PULLEYS WERE RETURNED.

    Additional Manufacturer Narrative · 0

    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. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    PLEASE REFER TO H10 FOR ANY FOLLOW UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, WHEN THE FENESTRATED BIPOLAR FORCEPS (FBF) WAS REMOVED FROM THE AUTOCLAVE, WHICH WAS PROPERLY PACKED IN SURGICAL GRADE PAPER, THE PRESENCE OF TWO LOOSE PIECES INSIDE THE WRAPPING WAS OBSERVED. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS MADE FOLLOW-UP ATTEMPT 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
    2171964 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K14220110 0402 00886874119808

    Patients

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