BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 24607408 · Received March 16, 2026

    Report

    Report Number
    2955842-2026-16237
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 16, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE E200 GENERATOR, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE VESSEL SEALER EXTEND (VSE) INSTRUMENT TO PERFORM FAILURE ANALYSIS. CONCOMITANT PRODUCTS: E-200 GENERATOR (PART NUMBER: 374897-41).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, A VESSEL WITH A DIAMETER OF 1.5¿2.0MM WAS COAGULATED AND TRANSECTED USING THE VESSEL SEALER EXTEND (VSE) INSTRUMENT, POWERED BY THE E200 GENERATOR. ALTHOUGH THE PROCEDURE WAS COMPLETED AS PLANNED, SEVERAL HOURS POSTOPERATIVELY THE PATIENT EXPERIENCED A HEMORRHAGE REQUIRING EMERGENT REOPERATION. THE SURGEON REPORTED THAT THE VESSEL, INITIALLY SEALED WITH THE VSE INSTRUMENT, SUBSEQUENTLY DEHISCED, RESULTING IN POSTOPERATIVE BLEEDING. THE SURGEON ATTRIBUTED THIS EVENT TO DIFFERENCES IN THE VSE INSTRUMENT'S PERFORMANCE WITH THE E200 GENERATOR, SPECIFICALLY NOTING A SIGNIFICANTLY SHORTER BIPOLAR ACTIVATION TIME. AS A RESULT, THE SURGEON FOUND THE VESSEL SEALS TO BE UNRELIABLE, REQUIRING THREE ACTIVATIONS OF THE VSE INSTRUMENT PER COAGULATION TASK INSTEAD OF THE USUAL SINGLE ACTIVATION. THIS ADJUSTMENT HAS LED TO A SLOWER OPERATIVE PACE AND AN EXTENDED PROCEDURAL DURATION. THE FOLLOWING INFORMATION REMAINS UNKNOWN: WHETHER ANY AUDIBLE TONES WERE HEARD DURING THE VSE INSTRUMENT SEALING EVENTS, WHICH VESSEL WAS INVOLVED, WHETHER ANY BLEEDING OCCURRED, AND WHETHER ANY MEDICAL INTERVENTIONS WERE PERFORMED AS A RESULT OF THESE EVENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605873 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422 N/A

    Patients

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