BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20637307 · Received November 8, 2024

    Report

    Report Number
    2955842-2024-21649
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 17, 2024
    Report Date
    October 21, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FORCE BIPOLAR INSTRUMENT FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    THE FORCE BIPOLAR INSTRUMENT WAS RECEIVED AND FAILURE ANALYSIS FOUND THE INSTRUMENT TO HAVE ONE BENT GRIP, CAUSING MISALIGNMENT OF THE GRIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT WAS HOLDING TISSUE AND THE JAWS WOULD NOT OPEN. THE ROBOTICS COORDINATOR CONFIRMED THAT THE PROCEDURE WAS A UNILATERAL INGUINAL HERNIA REPAIR PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE JAWS OF THE FORCE BIPOLAR INSTRUMENT FAILED TO RELEASE THE TISSUE OF THE HERNIA SAC AND SPERMATIC CORD. THE SURGEON ACTIVATED THE EMERGENCY-STOP BUTTON AND ATTEMPTED TO RELEASE THE INSTRUMENT'S JAWS USING THE INSTRUMENT RELEASE KIT (IRK), HOWEVER, THIS WAS UNSUCCESSFUL. THE SURGEON THEN USED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT TO PRY THE INSTRUMENT'S JAWS OPEN. A SMALL AMOUNT OF BLEEDING OCCURRED IN THE TISSUE, WITH 3 ML OF BLOOD LOSS REPORTED. THIS BLEEDING STOPPED ON ITS OWN AND DID NOT REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION. NO TISSUE WAS EXCISED DUE TO THIS COMPLICATION, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY USING NEW INSTRUMENTS. NO POST OPERATIVE COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944494 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K11240229 0484 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES