BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 22093584 · Received May 28, 2025

    Report

    Report Number
    2955842-2025-22240
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 1, 2025
    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
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR INSTRUMENT WAS ANALYZED AND CONFIRMED INITIAL FA FINDINGS, THE INSTRUMENT EXHIBITS A BROKEN MOLDED INSULATOR ON THE UPPER GRIP. THE INSTRUMENT WAS TRANSFERRED TO ENGINEERING FOR FURTHER INSPECTION AND NO ADDITIONAL FINDINGS WERE OBSERVED. THE GRIP BASE OF THE GRIP WITH THE BROKEN MOLDED INSULATOR WAS INSPECTION FOR TORSION, AND NO TORSION WAS OBSERVED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE MAY BE ATTRIBUTED TO MECHANICAL IMPACT OR EXCESSIVE FORCE APPLIED TO THE JAWS, SUCH AS AN ACCIDENTAL DROP OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE BROKEN MOLDED INSULATOR ON THE UPPER JAW. THE BROKEN PIECE MEASURED APPROXIMATELY 3.25 MM X 9.00 MM AND WAS NOT RETURNED WITH THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DOES NOT APPEAR TO BE BENT. THE DETACHED FRAGMENT WAS A RESULT OF THE BROKEN MOLDED INSULATOR. THE BROKEN PIECE WAS NOT RETURNED. IN ADDITION, IT WAS NOTED THE INSTRUMENT¿S UPPER GRIP TIP BECAME DISLODGED BECAUSE OF THE BREAK AND WAS ALSO NOT RETURNED WITH THE INSTRUMENT. THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE USER.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD A DAMAGED JAW. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729663 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430010-62 K11250109 0007 00886874114322

    Patients

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