BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 20564347 · Received October 30, 2024

    Report

    Report Number
    2955842-2024-21323
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 8, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114322
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 6MM MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE MOLDED INSULATOR BROKEN. AS A RESULT THE GRIP TIP BECAME DISLODGED AND THE CONDUCTOR WIRE WAS BROKEN. THE BROKEN PIECE MEASURES APPROXIMATELY 1.90MM X 9.90MM IN SIZE. THE BROKEN PIECE WAS NOT RETURNED. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO USER. ADDITIONAL FINDINGS NOT REPORTED BY SITE. THE INSTRUMENT WAS FOUND TO HAVE ONE OF THE GRIP TIPS DISLODGED. THE DISLODGED GRIP TIP WAS NOT RETURNED WITH THE INSTRUMENT. . THE COMPLAINT REGARDING FORCEPS TIP BROKEN WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT WAS FURTHER INVESTIGATED BY FAILURE ANALYSIS ENGINEER. INITIAL FAILURE ANALYSIS WAS CONFIRMED. THE INSTRUMENT EXHIBITS A BROKEN MOLDED INSULATOR ON THE LOWER GRIP. NO ADDITIONAL FINDINGS WERE OBSERVED. THE GRIP BASE DOES NOT APPEAR TO BE BENT ON THE GRIP WITH THE BROKEN MOLDED INSULATOR, AND THE GRIP WITH THE INTACT MOLDED INSULATOR DOES NOT APPEAR TO EXHIBIT BENDING OR PHYSICAL DAMAGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ISI HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TIP WAS BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTED THE TIP WAS INSPECTED BEFORE USAGE AND THEREFORE NOTICED THAT THE TIP WAS BROKEN. ALL OTHER INFORMATION REQUESTED WAS UNABLE TO BE ANSWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020325 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430010-57 U11220929 0013 00886874114322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.