BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22539286 · Received July 18, 2025

    Report

    Report Number
    2955842-2025-30462
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 6, 2025
    Report Date
    June 23, 2025
    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
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT, HOWEVER, INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO REPRODUCE/CONFIRM THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE WITHIN THE BIPOLAR YAW PULLEY, BETWEEN THE WIRE CRIMP ON THE GRIP AND THE SILICONE POTTING, WHICH SEALS THE WIRE ENTRANCE TO THE YAW PULLEY. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO DAMAGE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY RADICAL EXTRAPERITONEAL WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS OBSERVED TO HAVE A DAMAGED CONDUCTOR CABLE. THERE WAS NO TISSUE DAMAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE DISTRIBUTOR AND OBTAINED THE FOLLOWING INFORMATION: THE BLACK CABLE WAS COMPLETELY BROKEN. THERE WAS LOSS OF CAUTERY DUE TO THE FAILURE. THERE WERE NO SIGNS OF ARCING OR THERMAL DAMAGE. THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT DURING THE PROCEDURE AND THERE WAS NO SIGN OF ARCING. THE DISTRIBUTOR DID NOT KNOW WHAT OTHER INSTRUMENTS WERE IN USE WHEN THE ISSUE OCCURRED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878505 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K13241121 0012 00886874119808

    Patients

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